Trial Outcomes & Findings for Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors (NCT NCT03138889)
NCT ID: NCT03138889
Last Updated: 2023-03-10
Results Overview
DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg. A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
162 participants
Primary outcome timeframe
DLTs were assessed at 21 days from Cycle 1
Results posted on
2023-03-10
Participant Flow
Participant milestones
| Measure |
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + pembrolizumab 200 mg
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + atezolizumab 1200 mg
NKTR-214: Specified dose on specified days Atezolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) + chemotherapy
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
23
|
4
|
7
|
7
|
75
|
17
|
17
|
|
Overall Study
COMPLETED
|
7
|
18
|
4
|
5
|
6
|
72
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
0
|
2
|
1
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + pembrolizumab 200 mg
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + atezolizumab 1200 mg
NKTR-214: Specified dose on specified days Atezolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) + chemotherapy
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
0
|
2
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
n=12 Participants
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + pembrolizumab 200 mg
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
n=23 Participants
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + atezolizumab 1200 mg
NKTR-214: Specified dose on specified days Atezolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=4 Participants
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=7 Participants
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
n=7 Participants
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
n=75 Participants
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=17 Participants
NKTR-214 (0.010 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
n=17 Participants
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) + chemotherapy
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age < 65
|
5 participants
n=5 Participants
|
11 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
35 participants
n=8 Participants
|
6 participants
n=8 Participants
|
9 participants
n=24 Participants
|
74 participants
n=42 Participants
|
|
Age, Customized
Age 65-84
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
40 participants
n=8 Participants
|
11 participants
n=8 Participants
|
8 participants
n=24 Participants
|
87 participants
n=42 Participants
|
|
Age, Customized
Age 85 and Over
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
57 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
105 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
144 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
151 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
23 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
25 participants
n=8 Participants
|
3 participants
n=8 Participants
|
15 participants
n=24 Participants
|
96 participants
n=42 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
16 participants
n=8 Participants
|
2 participants
n=8 Participants
|
2 participants
n=24 Participants
|
20 participants
n=42 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
32 participants
n=8 Participants
|
12 participants
n=8 Participants
|
0 participants
n=24 Participants
|
44 participants
n=42 Participants
|
|
ECOG
ECOG 0
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
75 Participants
n=42 Participants
|
|
ECOG
ECOG 1
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
87 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: DLTs were assessed at 21 days from Cycle 1DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg. A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.
Outcome measures
| Measure |
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=4 Participants
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=7 Participants
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
n=7 Participants
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Total
Total (N=18)
|
|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a
At least 1 DLT
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a
Vascular Disorders: Hypotension
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: AEs reported starting immediately after first dose of study drug(s) until 100 days after the last dose of all study drugs, up to approximately 28 months.Safety and Tolerability of NKTR-214 (starting at dose of 0.008 mg/kg) in combination with pembrolizumab (Keytruda®) as evaluated by incidence of drug-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to drug discontinuation, and fatal AEs.
Outcome measures
| Measure |
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=4 Participants
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=7 Participants
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
n=7 Participants
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Total
n=18 Participants
Total (N=18)
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.
Subjects Reporting at Least One TEAE
|
4 Participants
|
7 Participants
|
7 Participants
|
18 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.
Subjects Reporting at Least One Serious TEAE
|
2 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.
Subjects Reporting at Least One TEAE Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.
Subjects Reporting at Least One TEAE Leading to Drug Discontinuation
|
2 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discontinue treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.ORR per BICR by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 2 and 3. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response.
Outcome measures
| Measure |
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=60 Participants
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=13 Participants
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Total
Total (N=18)
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.
|
13 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discont. treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.ORR per Investigator's Assessment\* by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 4 +5. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response. Objective response is the sum of confirmed complete response and confirmed partial response. \*Efficacy endpoint for Cohort 4 +5 is per Investigator's Assessment due to the early termination of the study and incompleteness of BICR data for these cohorts.
Outcome measures
| Measure |
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=8 Participants
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Total
Total (N=18)
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) Per Investigator's Assessment by RECIST 1.1 of NKTR-214 at a Dose of 0.006 mg/kg With Pembrolizumab and Platinum-based Chemotherapy for Dose Expansion Cohorts 4+5.
|
2 Participants
|
—
|
—
|
—
|
Adverse Events
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
Serious events: 5 serious events
Other events: 12 other events
Deaths: 4 deaths
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
Serious events: 14 serious events
Other events: 23 other events
Deaths: 18 deaths
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 5 deaths
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
Serious events: 30 serious events
Other events: 74 other events
Deaths: 39 deaths
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
Serious events: 10 serious events
Other events: 16 other events
Deaths: 5 deaths
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
Serious events: 8 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
n=12 participants at risk
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + pembrolizumab 200 mg
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
n=23 participants at risk
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + atezolizumab 1200 mg
NKTR-214: Specified dose on specified days Atezolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=4 participants at risk
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=7 participants at risk
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
n=7 participants at risk
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
n=75 participants at risk
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=17 participants at risk
"NKTR-214 (0.010 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
n=17 participants at risk
"NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) + chemotherapy
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.0%
6/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Lung infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Chills
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Fatigue
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
Other adverse events
| Measure |
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
n=12 participants at risk
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + pembrolizumab 200 mg
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
n=23 participants at risk
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + atezolizumab 1200 mg
NKTR-214: Specified dose on specified days Atezolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
n=4 participants at risk
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=7 participants at risk
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
n=7 participants at risk
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
n=75 participants at risk
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
n=17 participants at risk
"NKTR-214 (0.010 mg/kg) + pembrolizumab (200 mg)
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
n=17 participants at risk
"NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) + chemotherapy
NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
6/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
21.7%
5/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
57.1%
4/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
21.3%
16/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
29.4%
5/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
41.2%
7/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
5/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
26.1%
6/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
57.1%
4/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
16.0%
12/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
29.4%
5/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Pyrexia
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
34.8%
8/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
100.0%
7/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
57.1%
4/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
40.0%
30/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
47.1%
8/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Fatigue
|
50.0%
6/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
60.9%
14/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
85.7%
6/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
42.9%
3/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
29.3%
22/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
29.4%
5/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
23.5%
4/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Chills
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
75.0%
3/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
42.9%
3/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
85.7%
6/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.7%
11/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Asthenia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
29.3%
22/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
29.4%
5/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Influenza like illness
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
21.7%
5/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.3%
13/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Oedema peripheral
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
26.1%
6/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
10.7%
8/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Malaise
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Catheter site pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Face oedema
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Axillary pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Chest discomfort
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Feeling abnormal
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Infusion site extravasation
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
General disorders
Puncture site pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
6/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
34.8%
8/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
100.0%
7/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
42.9%
3/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
24.0%
18/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
35.3%
6/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
58.8%
10/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
10.7%
8/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
23.5%
4/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Gastric ulcer
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
4/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.4%
4/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
57.1%
4/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
42.9%
3/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
18.7%
14/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.3%
13/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
23.5%
4/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.0%
6/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Keratolysis exfoliativa acquired
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
16.0%
12/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
23.5%
4/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
42.9%
3/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
16.0%
12/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.3%
10/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Blood creatinine increased
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.3%
10/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.0%
6/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Amylase increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Lipase increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
International normalised ratio increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Weight increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Troponin I increased
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Troponin increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Blood creatine increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Clostridium test positive
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.4%
4/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
42.9%
3/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
26.7%
20/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
18.7%
14/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.4%
4/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
57.1%
4/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.3%
19/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
10.7%
8/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.4%
4/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
9.3%
7/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
43.5%
10/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
20.0%
15/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
23.5%
4/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
12.0%
9/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
4/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
30.4%
7/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.0%
6/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.6%
3/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Sinus headache
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Disturbance in attention
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Dyskinesia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Hyperaesthesia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
6.7%
5/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Candida infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Lung infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Oral candidiasis
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
17.3%
13/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
28.6%
2/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.7%
11/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
9.3%
7/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Embolism
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
75.0%
3/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
11.8%
2/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
2.7%
2/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
12.0%
9/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
23.5%
4/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.3%
10/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
13.0%
3/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Micturition urgency
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Eye swelling
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Uveitis
|
16.7%
2/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Blepharitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Eye pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Keratitis
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Vitreous floaters
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.3%
4/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
8.7%
2/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
50.0%
2/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.0%
3/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
4.3%
1/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
25.0%
1/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
1.3%
1/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Reproductive system and breast disorders
Penile pain
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Ear and labyrinth disorders
Deafness
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
8.3%
1/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
14.3%
1/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/12 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/23 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/4 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/7 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/75 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
0.00%
0/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
5.9%
1/17 • AEs will be reported starting immediately after the patient has been administered the first dose of study drug(s) until 100 days after the last dose of all study drug(s) up to 28 months. All study treatment-related SAEs that have not resolved by the end of treatment (EOT) visit will be followed until any of the following occur (whichever comes first): the event resolves or has stabilized or event returns to baseline (if a baseline value is available), or the patient dies or is lost to follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place