Trial Outcomes & Findings for A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) (NCT NCT04225117)
NCT ID: NCT04225117
Last Updated: 2026-04-13
Results Overview
Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
329 participants
Primary outcome timeframe
Up to 20.04 months
Results posted on
2026-04-13
Participant Flow
Participants of either gender, over 18 years of age, who were either previously treated for locally advanced or metastatic malignant solid tumours (Cohorts 1-8) or who had no previous treatment (Cohort 9), were enrolled in this study. Cohort 9 enrolment began after protocol amendment 5 was implemented.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Participants initially enrolled into Cohort 6 were reallocated based on disease type and histology into Cohorts 7 or 8. Data for all participants who had been enrolled into Cohort 6 is presented in either Cohort 7 or 8 based on the histology of the participant's tumor.
Participant milestones
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
Participants with hormone receptor positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2)- breast cancer received 1.25 mg/kg of enfortumab vedotin as an intravenous (IV) infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
Participants with triple negative breast cancer (TNBC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
Participants with squamous non-small cell lung cancer (NSCLC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
Participants with gastric and esophageal adenocarcinoma (EAC) (including gastroesophageal junction \[GEJ\] adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
Participants with esophageal squamous cell carcinoma (ESCC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 9: HNSCC
Participants with previously untreated head and neck squamous cell carcinoma (HNSCC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1 and 8 of each 21-day cycle. Participants also received 200 mg of pembrolizumab as an IV infusion on Day 1 of each 21-day cycle until one of the treatment discontinuation criteria were met. Enrolment into Cohort 9 began following protocol amendment 5.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
45
|
42
|
23
|
45
|
46
|
42
|
45
|
41
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
45
|
42
|
23
|
45
|
46
|
42
|
45
|
41
|
Reasons for withdrawal
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
Participants with hormone receptor positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2)- breast cancer received 1.25 mg/kg of enfortumab vedotin as an intravenous (IV) infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
Participants with triple negative breast cancer (TNBC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
Participants with squamous non-small cell lung cancer (NSCLC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
Participants with gastric and esophageal adenocarcinoma (EAC) (including gastroesophageal junction \[GEJ\] adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
Participants with esophageal squamous cell carcinoma (ESCC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 9: HNSCC
Participants with previously untreated head and neck squamous cell carcinoma (HNSCC) received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1 and 8 of each 21-day cycle. Participants also received 200 mg of pembrolizumab as an IV infusion on Day 1 of each 21-day cycle until one of the treatment discontinuation criteria were met. Enrolment into Cohort 9 began following protocol amendment 5.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Did Not Receive Any Amount of Study Intervention
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
2
|
2
|
4
|
8
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
4
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
36
|
30
|
20
|
33
|
37
|
34
|
39
|
9
|
|
Overall Study
Miscellaneous
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Ongoing
|
4
|
4
|
0
|
4
|
4
|
0
|
1
|
30
|
Baseline Characteristics
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
Baseline characteristics by cohort
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 Participants
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 Participants
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 Participants
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 Participants
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 Participants
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 Participants
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 9: HNSCC
n=41 Participants
Participants with previously untreated HNSCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1 and 8 of each 21-day cycle. Participants also received 200 mg of pembrolizumab as an IV infusion on Day 1 of each 21-day cycle until one of the treatment discontinuation criteria were met. Enrolment into Cohort 9 began following protocol amendment 5.
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
22 Participants
n=112 Participants
|
40 Participants
n=103 Participants
|
30 Participants
n=539 Participants
|
36 Participants
n=8 Participants
|
31 Participants
n=21 Participants
|
172 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
4 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=193 Participants
|
40 Participants
n=193 Participants
|
22 Participants
n=386 Participants
|
41 Participants
n=112 Participants
|
43 Participants
n=103 Participants
|
37 Participants
n=539 Participants
|
40 Participants
n=8 Participants
|
38 Participants
n=21 Participants
|
301 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
3 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=21 Participants
|
13 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
9 Participants
n=112 Participants
|
15 Participants
n=103 Participants
|
11 Participants
n=539 Participants
|
38 Participants
n=8 Participants
|
9 Participants
n=21 Participants
|
103 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=193 Participants
|
25 Participants
n=193 Participants
|
17 Participants
n=386 Participants
|
31 Participants
n=112 Participants
|
27 Participants
n=103 Participants
|
29 Participants
n=539 Participants
|
2 Participants
n=8 Participants
|
29 Participants
n=21 Participants
|
192 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
3 Participants
n=103 Participants
|
2 Participants
n=539 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=21 Participants
|
18 Participants
n=113 Participants
|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 9.8 • n=193 Participants
|
53.5 Years
STANDARD_DEVIATION 11.3 • n=193 Participants
|
65.5 Years
STANDARD_DEVIATION 8.5 • n=386 Participants
|
65.7 Years
STANDARD_DEVIATION 10.4 • n=112 Participants
|
63.2 Years
STANDARD_DEVIATION 9.5 • n=103 Participants
|
59.5 Years
STANDARD_DEVIATION 12 • n=539 Participants
|
64.9 Years
STANDARD_DEVIATION 9 • n=8 Participants
|
66.5 Years
STANDARD_DEVIATION 7.9 • n=21 Participants
|
61.8 Years
STANDARD_DEVIATION 10.8 • n=113 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=193 Participants
|
42 Participants
n=193 Participants
|
10 Participants
n=386 Participants
|
21 Participants
n=112 Participants
|
6 Participants
n=103 Participants
|
12 Participants
n=539 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=21 Participants
|
154 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Up to 20.04 monthsPopulation: Response Evaluable Set (RES) in Cohorts 1-8: all FAS participants who had measurable disease at baseline per investigator assessment and either had at least 2 postbaseline response assessments or were no longer in the follow-up of response at the time of analysis.
Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson).
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 Participants
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 Participants
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 Participants
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 Participants
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 Participants
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 Participants
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment
|
15.6 Percentage of participants
Interval 6.49 to 29.46
|
19.0 Percentage of participants
Interval 8.6 to 34.12
|
4.3 Percentage of participants
Interval 0.11 to 21.95
|
16.3 Percentage of participants
Interval 6.81 to 30.7
|
23.9 Percentage of participants
Interval 12.59 to 38.77
|
9.5 Percentage of participants
Interval 2.66 to 22.62
|
18.2 Percentage of participants
Interval 8.19 to 32.71
|
PRIMARY outcome
Timeframe: Up to 12.85 monthsPopulation: RES in Cohort 9: All FAS participants who had measurable disease at baseline per investigator assessment and either had at least 2 postbaseline response assessments or were no longer in the follow-up of response at the time of analysis.
Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson).
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=41 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment
|
39.0 Percentage of participants
Interval 24.2 to 55.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20.04 monthsPopulation: RES in Cohorts 1-8: participants with confirmed CR or PR.
DOR was defined as the time from the date of first documented response (CR or PR that is subsequently confirmed) to the date of first documented progressive disease (PD) per RECIST V1.1 or death due to any cause, whichever occurs first. DOR was only calculated for participants achieving a confirmed CR or PR, based on Kaplan-Meier estimate.
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=7 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=8 Participants
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=1 Participants
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=7 Participants
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=11 Participants
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=4 Participants
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=8 Participants
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohorts 1-8: Duration of Resonse (DOR) Per RECIST V.1.1 Per Investigator Assessment
|
7.23 Months
Interval 3.52 to 7.23
|
3.78 Months
Interval 1.87 to 3.94
|
3.71 Months
Confidence interval could not be calculated as only 1 participant was analyzed.
|
10.15 Months
Interval 9.69 to 10.38
|
9.43 Months
Interval 2.53 to
Upper confidence interval was not reached due to insufficient events above the median.
|
10.32 Months
Interval 1.64 to 10.32
|
3.88 Months
Interval 2.33 to 7.39
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: RES in Cohorts 1-8: All FAS participants who had measurable disease at baseline per investigator assessment and either had at least 2 postbaseline response assessments or were no longer in the follow-up of response at the time of analysis.
DCR was defined as the percentage of participants whose Best Overall Response (BOR) was confirmed CR or PR or stable disease (SD) (≥ 7 weeks).
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 Participants
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 Participants
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 Participants
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 Participants
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 Participants
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 Participants
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohorts 1-8: Disease Control Rate (DCR) Per RECIST V1.1 Per Investigator Assessment
|
51.1 Percentage of participants
Interval 35.77 to 66.3
|
57.1 Percentage of participants
Interval 40.96 to 72.28
|
65.2 Percentage of participants
Interval 42.73 to 83.62
|
67.4 Percentage of participants
Interval 51.46 to 80.92
|
56.5 Percentage of participants
Interval 41.11 to 71.07
|
47.6 Percentage of participants
Interval 32.0 to 63.58
|
45.5 Percentage of participants
Interval 30.39 to 61.15
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: FAS in Cohorts 1-8: All enrolled participants who received any amount of study intervention.
PFS was defined as the time from start of study intervention to first documentation of objective tumor progression or death due to any cause, whichever comes first, based on Kaplan-Meier estimate.
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 Participants
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 Participants
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 Participants
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 Participants
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 Participants
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 Participants
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohorts 1-8: Progression Free Survival (PFS) Per RECIST V1.1 Per Investigator Assessment
|
5.39 Months
Interval 3.35 to 5.68
|
3.52 Months
Interval 2.1 to 4.63
|
3.52 Months
Interval 1.91 to 5.42
|
4.11 Months
Interval 2.76 to 5.72
|
3.94 Months
Interval 2.79 to 4.67
|
3.06 Months
Interval 1.77 to 3.71
|
2.10 Months
Interval 1.87 to 3.71
|
SECONDARY outcome
Timeframe: Up to 34 monthsOS was defined as the time from start of study treatment to date of death due to any cause, based on Kaplan-Meier estimate. In the absence of confirmed death, OS was censored at the last date the participant was known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment + 30 days (32 months)Population: FAS in Cohorts 1-8: All enrolled participants who received any amount of study intervention.
A TEAE is any untoward medical occurrence in a participant administered enfortumab vedotin, and which does not necessarily have to have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of enfortumab vedotin whether or not considered related to the enfortumab vedotin. A TEAE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by a TEAE); or other medically important events.
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 Participants
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 Participants
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 Participants
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 Participants
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 Participants
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 Participants
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohorts 1-8: Number of Participants With Treatment-emergent Adverse Events (AEs)
TEAEs
|
45 Participants
|
42 Participants
|
22 Participants
|
42 Participants
|
45 Participants
|
42 Participants
|
43 Participants
|
|
Cohorts 1-8: Number of Participants With Treatment-emergent Adverse Events (AEs)
Serious TEAEs
|
12 Participants
|
9 Participants
|
8 Participants
|
16 Participants
|
22 Participants
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 12.85 monthsPopulation: RES in Cohort 9: All FAS participants who had measurable disease at baseline per investigator assessment and either had at least 2 postbaseline response assessments or were no longer in the follow-up of response at the time of analysis.
DOR was defined as the time from the date of first documented response (CR or PR that is subsequently confirmed) to the date of first documented PD per RECIST V1.1 or death due to any cause, whichever occurs first. DOR was only calculated for participants achieving a confirmed CR or PR, based on Kaplan-Meier estimate.
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=16 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohort 9: DOR Per RECIST V.1.1 Per Investigator Assessment
|
NA Months
Interval 5.78 to
Median and upper confidence interval were not reached due to censoring of 14 participants (insufficient events).
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 15 monthsPopulation: RES in Cohort 9: All FAS participants who had measurable disease at baseline per investigator assessment and either had at least 2 postbaseline response assessments or were no longer in the follow-up of response at the time of analysis.
DCR was defined as the percentage of participants whose BOR is confirmed CR or PR or SD (≥ 7 weeks).
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=41 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohort 9: DCR Per RECIST V1.1 Per Investigator Assessment
|
75.6 Percentage of participants
Interval 59.7 to 87.64
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 15 monthsPopulation: FAS in Cohort 9: All enrolled participants who received any amount of study intervention.
PFS was defined as the time from start of study intervention to first documentation of objective tumor progression or death due to any cause, whichever comes first, based on Kaplan-Meier estimate.
Outcome measures
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=41 Participants
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Cohort 9: PFS Per RECIST V1.1 by Investigator Assessment
|
5.06 Months
Interval 3.45 to
Upper confidence interval was not reached due to insufficient events above the median.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 15.4 monthsOS was defined as the time from start of study treatment to date of death due to any cause, based on Kaplan-Meier estimate. In the absence of confirmed death, OS was censored at the last date the participant was known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of treatment + 30 day (15 months)A TEAE is any untoward medical occurrence in a participant administered enfortumab vedotin, and which does not necessarily have to have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of enfortumab vedotin whether or not considered related to the enfortumab vedotin. A TEAE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: HR+/HER2- Breast Cancer
Serious events: 12 serious events
Other events: 44 other events
Deaths: 36 deaths
Cohort 2: TNBC Cancer
Serious events: 9 serious events
Other events: 42 other events
Deaths: 30 deaths
Cohort 3: Squamous NSCLC
Serious events: 8 serious events
Other events: 21 other events
Deaths: 20 deaths
Cohort 4: Non-squamous NSCLC
Serious events: 16 serious events
Other events: 42 other events
Deaths: 33 deaths
Cohort 5: Head and Neck Cancer
Serious events: 22 serious events
Other events: 42 other events
Deaths: 38 deaths
Cohort 7: EAC
Serious events: 14 serious events
Other events: 41 other events
Deaths: 34 deaths
Cohort 8: ESCC
Serious events: 12 serious events
Other events: 42 other events
Deaths: 39 deaths
Cohort 9: HNSCC
Serious events: 21 serious events
Other events: 39 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 participants at risk
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 participants at risk
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 participants at risk
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 participants at risk
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 participants at risk
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 participants at risk
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 participants at risk
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 9: HNSCC
n=41 participants at risk
Participants with previously untreated HNSCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1 and 8 of each 21-day cycle. Participants also received 200 mg of pembrolizumab as an IV infusion on Day 1 of each 21-day cycle until one of the treatment discontinuation criteria were met. Enrolment into Cohort 9 began following protocol amendment 5.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Dry eye
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Asthenia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Chest discomfort
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Death
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Disease progression
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Fatigue
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Pain
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Pyrexia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Hepatobiliary disorders
Acute on chronic liver failure
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
COVID-19
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Sepsis
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Septic shock
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Wound infection
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
1/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Dermatomyositis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Necrotising myositis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Syncope
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Product Issues
Device dislocation
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Product Issues
Device malfunction
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Psychiatric disorders
Confusional state
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Speech disorder
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Vascular disorders
Embolism
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Vascular disorders
Hypotension
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Vascular disorders
Shock
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
Other adverse events
| Measure |
Cohort 1: HR+/HER2- Breast Cancer
n=45 participants at risk
Participants with HR+/ HER2- breast cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 2: TNBC Cancer
n=42 participants at risk
Participants with TNBC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 3: Squamous NSCLC
n=23 participants at risk
Participants with squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 4: Non-squamous NSCLC
n=43 participants at risk
Participants with non-squamous NSCLC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 5: Head and Neck Cancer
n=46 participants at risk
Participants with head and neck cancer received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 7: EAC
n=42 participants at risk
Participants with gastric and EAC (including GEJ adenocarcinoma received 1.25 kg/mg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 8: ESCC
n=44 participants at risk
Participants with ESCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1, 8 and 15 of each 28-day cycle until one of the treatment discontinuation criteria were met.
|
Cohort 9: HNSCC
n=41 participants at risk
Participants with previously untreated HNSCC received 1.25 mg/kg of enfortumab vedotin as an IV infusion on Days 1 and 8 of each 21-day cycle. Participants also received 200 mg of pembrolizumab as an IV infusion on Day 1 of each 21-day cycle until one of the treatment discontinuation criteria were met. Enrolment into Cohort 9 began following protocol amendment 5.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.8%
4/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.4%
2/45 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.6%
6/44 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Cardiac disorders
Tachycardia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
5/45 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.4%
9/42 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.1%
6/23 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.7%
10/46 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
19.0%
8/42 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
18.2%
8/44 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
19.5%
8/41 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Fatigue
|
46.7%
21/45 • Number of events 23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
31.0%
13/42 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
52.2%
12/23 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
37.2%
16/43 • Number of events 20 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
30.4%
14/46 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
35.7%
15/42 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
20.5%
9/44 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
46.3%
19/41 • Number of events 28 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Malaise
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.6%
5/43 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
20.5%
9/44 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Dry eye
|
15.6%
7/45 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Eye discharge
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Eye pain
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Lacrimation increased
|
11.1%
5/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Eye disorders
Vision blurred
|
8.9%
4/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.8%
4/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.8%
8/45 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
4/23 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Oedema peripheral
|
8.9%
4/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
10/45 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.1%
6/23 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
20.9%
9/43 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
15.2%
7/46 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
35.7%
15/42 • Number of events 17 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
18.2%
8/44 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
19.5%
8/41 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
12/45 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
34.8%
8/23 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
27.9%
12/43 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
23.9%
11/46 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
28.6%
12/42 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
36.6%
15/41 • Number of events 17 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Dry mouth
|
17.8%
8/45 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
5/45 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Nausea
|
37.8%
17/45 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
35.7%
15/42 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
34.8%
8/23 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
34.9%
15/43 • Number of events 21 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
8/46 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
31.0%
13/42 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
20.5%
9/44 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
31.7%
13/41 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
10.9%
5/46 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.8%
3/44 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
6/45 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
16.3%
7/43 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
15.2%
7/46 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.4%
9/42 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Asthenia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
General disorders
Pyrexia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
6/46 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
20.5%
9/44 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
COVID-19
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.8%
4/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Sinusitis
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
10/45 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.2%
11/42 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.1%
4/44 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
19.5%
8/41 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Aspartate aminotransferase increased
|
26.7%
12/45 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
28.6%
12/42 • Number of events 19 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
4/23 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.6%
5/43 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
10.9%
5/46 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
15.9%
7/44 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
22.0%
9/41 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
3/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
12.2%
5/41 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Lymphocyte count decreased
|
4.4%
2/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
12.2%
5/41 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Neutrophil count decreased
|
8.9%
4/45 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.0%
6/43 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.1%
4/44 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Platelet count decreased
|
4.4%
2/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
Weight decreased
|
11.1%
5/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.1%
6/23 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
27.9%
12/43 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
8/46 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
16.7%
7/42 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.4%
5/44 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.1%
7/41 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Investigations
White blood cell count decreased
|
6.7%
3/45 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.8%
3/44 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
9/45 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.2%
11/42 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
47.8%
11/23 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
30.2%
13/43 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.7%
10/46 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
38.1%
16/42 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
29.5%
13/44 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
22.0%
9/41 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.0%
6/43 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.4%
5/44 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.9%
4/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.6%
5/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
4/46 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
16.7%
7/42 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.1%
4/44 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
12.2%
5/41 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.4%
2/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
5/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.7%
5/23 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Dysgeusia
|
28.9%
13/45 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
31.0%
13/42 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
34.8%
8/23 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
32.6%
14/43 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
19.6%
9/46 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
33.3%
14/42 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
25.0%
11/44 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.6%
6/41 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Headache
|
11.1%
5/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
16.7%
7/42 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
5/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
4/23 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.8%
4/41 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Paraesthesia
|
4.4%
2/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
3/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
5/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
4/23 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.6%
5/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.9%
4/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.8%
3/44 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.1%
6/23 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
4/46 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.6%
5/43 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.3%
3/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Haematuria
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
6/45 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.7%
5/23 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
23.3%
10/43 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
4/46 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
12.2%
5/41 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.8%
4/41 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.6%
7/45 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.2%
11/42 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.1%
6/23 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
39.5%
17/43 • Number of events 17 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
28.3%
13/46 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.4%
5/44 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
22.0%
9/41 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Nervous system disorders
Taste disorder
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.6%
6/44 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Psychiatric disorders
Anxiety
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.3%
4/43 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Psychiatric disorders
Depression
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Psychiatric disorders
Insomnia
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
21.4%
9/42 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.8%
3/44 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.9%
2/41 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.9%
4/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
30.4%
7/23 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
18.6%
8/43 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
12.2%
5/41 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
28.9%
13/45 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
28.6%
12/42 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
4/23 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.0%
6/43 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.5%
3/46 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.1%
4/44 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.1%
7/41 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.4%
11/45 • Number of events 11 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
31.0%
13/42 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
39.1%
9/23 • Number of events 9 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
37.2%
16/43 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
28.3%
13/46 • Number of events 13 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
35.7%
15/42 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
18.2%
8/44 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
29.3%
12/41 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.9%
4/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.5%
4/42 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
13.0%
3/23 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
10.9%
5/46 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.8%
2/42 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
15.9%
7/44 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
22.0%
9/41 • Number of events 12 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.2%
19/45 • Number of events 28 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
33.3%
14/42 • Number of events 14 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
26.1%
6/23 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
37.2%
16/43 • Number of events 24 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
17.4%
8/46 • Number of events 8 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
28.6%
12/42 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
29.5%
13/44 • Number of events 15 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
24.4%
10/41 • Number of events 16 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
4.4%
2/45 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/43 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.7%
3/45 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
14.3%
6/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.5%
2/44 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.2%
1/45 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/43 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/46 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/42 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
6.8%
3/44 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Vascular disorders
Hypertension
|
4.4%
2/45 • Number of events 5 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
1/23 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.3%
1/44 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
9.8%
4/41 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Vascular disorders
Hypotension
|
0.00%
0/45 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/42 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
8.7%
2/23 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.7%
2/43 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.2%
1/46 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/44 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
2.4%
1/41 • Number of events 1 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.9%
4/45 • Number of events 4 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.1%
3/42 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
7.0%
3/43 • Number of events 3 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
4.3%
2/46 • Number of events 2 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.9%
5/42 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
11.4%
5/44 • Number of events 6 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
0.00%
0/41 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.4%
20/45 • Number of events 27 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
35.7%
15/42 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
34.8%
8/23 • Number of events 10 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
39.5%
17/43 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
15.2%
7/46 • Number of events 7 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
40.5%
17/42 • Number of events 23 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
29.5%
13/44 • Number of events 17 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
39.0%
16/41 • Number of events 18 • Cohorts 1-8: All-cause mortality: up to 34 months; AEs: up to end of treatment + 30 days (32 months). Cohort 9: All-cause mortality: up to 15 months; AEs: up to end of treatment + 30 days (15 months)
All-cause mortality: enrolled population; AEs: FAS.
|
Additional Information
Clinical Transparency
Astellas Pharma Global Development, Inc
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER