Trial Outcomes & Findings for Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (NCT NCT02760498)
NCT ID: NCT02760498
Last Updated: 2025-05-28
Results Overview
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
432 participants
Primary outcome timeframe
Up to 108 weeks
Results posted on
2025-05-28
Participant Flow
A total of 432 participants with advanced cutaneous squamous cell carcinoma (CSCC) (metastatic CSCC \[mCSCC\] or locally advanced CSCC \[laCSCC\]) were enrolled.
Participant milestones
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
78
|
56
|
63
|
9
|
167
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
59
|
78
|
56
|
63
|
9
|
165
|
|
Overall Study
Completed Treatment
|
24
|
20
|
22
|
27
|
5
|
50
|
|
Overall Study
COMPLETED
|
19
|
28
|
22
|
24
|
3
|
64
|
|
Overall Study
NOT COMPLETED
|
40
|
50
|
34
|
39
|
6
|
103
|
Reasons for withdrawal
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
1
|
1
|
0
|
6
|
|
Overall Study
Death
|
7
|
5
|
5
|
7
|
0
|
23
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Non-compliance with study drug
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant decision
|
1
|
4
|
2
|
2
|
1
|
6
|
|
Overall Study
Sponsor decision
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
4
|
1
|
4
|
0
|
2
|
|
Overall Study
Disease progression
|
21
|
19
|
20
|
18
|
4
|
55
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
5
|
1
|
0
|
6
|
|
Overall Study
Other than specified
|
1
|
6
|
0
|
3
|
1
|
0
|
|
Overall Study
Not treated
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
n=9 Participants
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=167 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
>= 75 years
|
20 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
94 Participants
n=8 Participants
|
204 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
83 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
130 Participants
n=8 Participants
|
349 Participants
n=8 Participants
|
|
Age, Customized
< 65 years
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
98 Participants
n=8 Participants
|
|
Age, Customized
>= 65 to < 75 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
130 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
147 Participants
n=8 Participants
|
405 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
18 Participants
n=8 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
164 Participants
n=8 Participants
|
420 Participants
n=8 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 108 weeksPopulation: The Full Analysis Set (FAS) included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this analysis.
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=167 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) by Independent Central Review
|
50.8 percentage of participants
Interval 37.5 to 64.1
|
44.9 percentage of participants
Interval 33.6 to 56.6
|
46.4 percentage of participants
Interval 33.0 to 60.3
|
61.9 percentage of participants
Interval 48.8 to 73.9
|
47.3 percentage of participants
Interval 39.5 to 55.2
|
—
|
SECONDARY outcome
Timeframe: Up to 108 weeksPopulation: The FAS included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
ORR was defined as percentage of participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm \<1 cm. -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=167 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
ORR by Investigator Assessment
|
50.8 percentage of participants
Interval 37.5 to 64.1
|
56.4 percentage of participants
Interval 44.7 to 67.6
|
55.4 percentage of participants
Interval 41.5 to 68.7
|
63.5 percentage of participants
Interval 50.4 to 75.3
|
52.7 percentage of participants
Interval 44.8 to 60.5
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR who were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
DOR was measured from the time measurement criteria were first met for CR/PR, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=30 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=35 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=26 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=39 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=79 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR) by Independent Central Review
|
NA months
Interval 20.7 to
Not reached due to insufficient number of events
|
41.9 months
Interval 20.5 to 54.6
|
41.3 months
Interval 40.8 to 46.3
|
NA months
Interval 30.5 to
Not reached due to insufficient number of events
|
31.6 months
Interval 29.5 to
Not reached due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=30 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=44 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=31 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=40 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=88 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
DOR by Investigator Assessment
|
NA months
Interval 30.7 to
Not reached due to insufficient number of events
|
41.9 months
Not reached due to insufficient number of events
|
44.2 months
Interval 25.4 to 44.2
|
NA months
Interval 27.1 to
Not reached due to insufficient number of events
|
NA months
Interval 29.5 to
Not reached due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=165 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) by Independent Central Review
|
18.4 months
Interval 7.3 to 53.2
|
18.5 months
Interval 11.1 to 43.8
|
21.7 months
Interval 3.8 to 43.3
|
32.2 months
Interval 16.6 to
Not reached due to insufficient number of events
|
16.6 months
Interval 12.4 to 31.5
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=165 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
PFS by Investigator Assessment
|
16.6 months
Interval 7.3 to
Not reached due to insufficient number of events
|
32.5 months
Interval 17.1 to 43.8
|
15.2 months
Interval 4.1 to 43.0
|
25.3 months
Interval 8.2 to
Not reached due to insufficient number of events
|
16.5 months
Interval 10.3 to 31.3
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
OS was measured from start of treatment until death due to any cause.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=165 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
57.7 months
Interval 29.3 to
Not reached due to insufficient number of events
|
NA months
Interval 58.3 to
Not reached due to insufficient number of events
|
48.4 months
Interval 29.5 to
Not reached due to insufficient number of events
|
NA months
Interval 28.6 to
Not reached due to insufficient number of events
|
NA months
Not reached due to insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: Up to 108 weeksPopulation: The FAS included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
CR rate was defined as percentage of participants with BOR of CR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm \<1 cm. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=167 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Complete Response (CR) Rate by Independent Central Review
|
20.3 percentage of participants
Interval 11.0 to 32.8
|
12.8 percentage of participants
Interval 6.3 to 22.3
|
19.6 percentage of participants
Interval 10.2 to 32.4
|
22.2 percentage of participants
Interval 12.7 to 34.5
|
10.8 percentage of participants
Interval 6.5 to 16.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, Up to Cycle 12 Day 1 (Week 89)Population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number Analyzed" is the number evaluable at each time point. Only Groups 1, 2, 3, and 4 were planned for this outcome measure.
EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=44 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=68 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=38 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=54 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C6D1
|
5.11 score on a scale
Standard Deviation 17.437
|
5.68 score on a scale
Standard Deviation 28.118
|
12.18 score on a scale
Standard Deviation 24.521
|
0.25 score on a scale
Standard Deviation 21.599
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C9D1
|
6.09 score on a scale
Standard Deviation 18.938
|
6.61 score on a scale
Standard Deviation 26.199
|
26.67 score on a scale
Standard Deviation 24.470
|
7.69 score on a scale
Standard Deviation 20.543
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C11D1
|
10.33 score on a scale
Standard Deviation 28.186
|
11.40 score on a scale
Standard Deviation 22.603
|
32.50 score on a scale
Standard Deviation 14.407
|
14.81 score on a scale
Standard Deviation 19.444
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C12D1
|
8.33 score on a scale
Standard Deviation 22.388
|
12.75 score on a scale
Standard Deviation 24.494
|
27.78 score on a scale
Standard Deviation 16.667
|
2.78 score on a scale
Standard Deviation 26.021
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C5D1
|
4.17 score on a scale
Standard Deviation 22.316
|
8.33 score on a scale
Standard Deviation 21.246
|
13.27 score on a scale
Standard Deviation 21.466
|
5.79 score on a scale
Standard Deviation 18.774
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
Cycle 2 Day 1 (C2D1)
|
0.00 score on a scale
Standard Deviation 21.464
|
5.56 score on a scale
Standard Deviation 18.895
|
6.86 score on a scale
Standard Deviation 19.621
|
0.96 score on a scale
Standard Deviation 17.670
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C3D1
|
11.26 score on a scale
Standard Deviation 19.267
|
5.30 score on a scale
Standard Deviation 21.717
|
15.28 score on a scale
Standard Deviation 20.655
|
3.88 score on a scale
Standard Deviation 15.680
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C4D1
|
6.25 score on a scale
Standard Deviation 25.069
|
8.76 score on a scale
Standard Deviation 19.585
|
13.51 score on a scale
Standard Deviation 22.539
|
4.39 score on a scale
Standard Deviation 15.099
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C7D1
|
6.51 score on a scale
Standard Deviation 17.676
|
9.17 score on a scale
Standard Deviation 22.393
|
22.22 score on a scale
Standard Deviation 23.659
|
4.44 score on a scale
Standard Deviation 18.598
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C8D1
|
4.60 score on a scale
Standard Deviation 21.080
|
10.10 score on a scale
Standard Deviation 21.425
|
30.30 score on a scale
Standard Deviation 19.816
|
5.00 score on a scale
Standard Deviation 25.158
|
—
|
—
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
C10D1
|
12.04 score on a scale
Standard Deviation 20.844
|
13.77 score on a scale
Standard Deviation 26.064
|
28.70 score on a scale
Standard Deviation 13.889
|
5.83 score on a scale
Standard Deviation 22.923
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 108 weeks plus 105 days (5 half-lives)Population: The Safety Analysis Set (SAF) included all enrolled participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=9 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=165 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
|
59 Participants
|
78 Participants
|
55 Participants
|
63 Participants
|
9 Participants
|
163 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The Pharmacokinetic (PK) analysis set included all participants who had received cemiplimab and had at least 1 qualified (non-missing) post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified point.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=58 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=75 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=52 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=62 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=9 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=162 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Peak Concentration (Cmax) of Cemiplimab
At Steady State
|
151 milligram per liter (mg/L)
Standard Deviation 83.7
|
148 milligram per liter (mg/L)
Standard Deviation 76.6
|
151 milligram per liter (mg/L)
Standard Deviation 46.2
|
281 milligram per liter (mg/L)
Standard Deviation 235
|
174 milligram per liter (mg/L)
Standard Deviation 62.2
|
142 milligram per liter (mg/L)
Standard Deviation 78.3
|
|
Peak Concentration (Cmax) of Cemiplimab
After the First Dose
|
108 milligram per liter (mg/L)
Standard Deviation 147
|
84.1 milligram per liter (mg/L)
Standard Deviation 105
|
132 milligram per liter (mg/L)
Standard Deviation 203
|
174 milligram per liter (mg/L)
Standard Deviation 50.1
|
52.9 milligram per liter (mg/L)
Standard Deviation 18.4
|
96.3 milligram per liter (mg/L)
Standard Deviation 56.2
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The PK analysis set included all participants who had received cemiplimab and had at least 1 qualified (non-missing) post-baseline measurement of cemiplimab concentration in serum. Here, "Overall number of participants analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified point.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=53 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=71 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=46 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=58 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=9 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=143 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Cemiplimab
At Steady State
|
69.9 mg/L
Standard Deviation 19.3
|
67.5 mg/L
Standard Deviation 29.8
|
62.7 mg/L
Standard Deviation 28.3
|
62.5 mg/L
Standard Deviation 24.1
|
65.9 mg/L
Standard Deviation 22.9
|
53.3 mg/L
Standard Deviation 20.1
|
|
Trough Concentration (Ctrough) of Cemiplimab
After the First Dose
|
21.5 mg/L
Standard Deviation 7.12
|
26.3 mg/L
Standard Deviation 14.3
|
33.6 mg/L
Standard Deviation 32.1
|
32.1 mg/L
Standard Deviation 10.4
|
34.1 mg/L
Standard Deviation 14.1
|
23.0 mg/L
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The Anti-drug Antibody (ADA) population for cemiplimab included all treated participants who had at least 1 postdose ADA result for cemiplimab.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=50 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=66 Participants
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=41 Participants
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=50 Participants
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=8 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=133 Participants
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 108 weeksPopulation: The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' is the number of participants who are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
ORR was defined as percentage of participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by immunohistochemistry (IHC). -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=96 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays
PD-L1 < 1%
|
40.5 percentage of participants
Interval 24.8 to 57.9
|
—
|
—
|
—
|
—
|
—
|
|
ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays
PD-L1 >= 1%
|
49.2 percentage of participants
Interval 35.9 to 62.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
DOR was measured from the time measurement criteria are first met for CR/PR, as defined in Outcome Measure 13, whichever was recorded first, until the first date of recurrent or PD or death due to any cause in participants with BOR of CR or PR. Expression level of PD-L1 was assessed in tumor biopsy samples by IHC. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=44 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays
PD-L1 < 1%
|
31.6 months
Interval 12.6 to
Not reached due to insufficient number of events
|
—
|
—
|
—
|
—
|
—
|
|
DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays
PD-L1 >= 1%
|
NA months
Not reached due to insufficient number of events
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 65 months (treatment period + follow-up including survival follow-up)Population: The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants who are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Outcome measures
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=96 Participants
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
|---|---|---|---|---|---|---|
|
PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays
PD-L1 < 1%
|
10.7 months
Interval 3.0 to 15.3
|
—
|
—
|
—
|
—
|
—
|
|
PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays
PD-L1 >= 1%
|
16.6 months
Interval 4.0 to
Not reached due to insufficient number of events
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Serious events: 24 serious events
Other events: 56 other events
Deaths: 27 deaths
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Serious events: 28 serious events
Other events: 75 other events
Deaths: 19 deaths
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Serious events: 23 serious events
Other events: 49 other events
Deaths: 26 deaths
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Serious events: 35 serious events
Other events: 59 other events
Deaths: 23 deaths
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
Serious events: 2 serious events
Other events: 9 other events
Deaths: 2 deaths
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Serious events: 85 serious events
Other events: 147 other events
Deaths: 59 deaths
Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W
Serious events: 4 serious events
Other events: 9 other events
Deaths: 2 deaths
Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 participants at risk
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 participants at risk
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 participants at risk
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 participants at risk
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
n=9 participants at risk
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=165 participants at risk
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W
n=12 participants at risk
Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 350 mg SC Q3W for up to a total (IV + SC) of 108 weeks.
|
Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W
n=7 participants at risk
Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 1050 mg SC Q6W for up to a total (IV + SC) of 108 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.6%
2/56 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.2%
2/63 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
1/59 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Product Issues
Device occlusion
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
4.8%
3/63 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.4%
4/165 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Delirium
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
2/59 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.6%
2/56 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pneumonia
|
3.4%
2/59 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
4.8%
3/63 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
4.2%
7/165 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Cellulitis
|
6.8%
4/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
4.8%
3/63 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Skin infection
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Wound infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.2%
2/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Arthritis infective
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Catheter site infection
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.2%
2/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Groin infection
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Meningitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Meningitis aseptic
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pyelonephritis
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.8%
4/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.2%
2/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.4%
4/165 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Death
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Fatigue
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Inflammation
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Sudden death
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Cerebral infarction
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.2%
2/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.4%
4/165 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
2.6%
2/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
3.2%
2/63 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.2%
2/165 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.3%
1/78 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.6%
1/63 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
1/56 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
1.8%
3/165 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.61%
1/165 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Hypophysitis
|
1.7%
1/59 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
Other adverse events
| Measure |
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
n=59 participants at risk
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
n=78 participants at risk
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
|
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
n=56 participants at risk
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
n=63 participants at risk
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
|
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
n=9 participants at risk
Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
|
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
n=165 participants at risk
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
|
Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W
n=12 participants at risk
Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 350 mg SC Q3W for up to a total (IV + SC) of 108 weeks.
|
Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W
n=7 participants at risk
Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 1050 mg SC Q6W for up to a total (IV + SC) of 108 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.8%
17/59 • Number of events 29 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
29.5%
23/78 • Number of events 42 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
23.2%
13/56 • Number of events 18 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
27.0%
17/63 • Number of events 23 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
33.3%
3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
23.6%
39/165 • Number of events 58 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Nausea
|
23.7%
14/59 • Number of events 17 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
25.6%
20/78 • Number of events 25 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
21.4%
12/56 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
20.0%
33/165 • Number of events 37 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
15.4%
12/78 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
6/59 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.1%
11/78 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
8/56 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
17/165 • Number of events 26 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Constipation
|
16.9%
10/59 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.8%
10/78 • Number of events 11 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
17.9%
10/56 • Number of events 11 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
23.8%
15/63 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
13.3%
22/165 • Number of events 25 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
5/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
8.5%
5/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
3/59 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Poor dental condition
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Gastrointestinal disorders
Toothache
|
6.8%
4/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Fatigue
|
25.4%
15/59 • Number of events 18 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
43.6%
34/78 • Number of events 41 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
30.4%
17/56 • Number of events 19 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
22.2%
14/63 • Number of events 15 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
26.7%
44/165 • Number of events 49 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Chills
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.7%
6/78 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.7%
6/78 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.1%
15/165 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Facial pain
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Oedema peripheral
|
6.8%
4/59 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.7%
6/56 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.7%
16/165 • Number of events 18 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Asthenia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
5/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
15.8%
26/165 • Number of events 35 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Catheter site rash
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.5%
9/165 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Injection site discomfort
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
General disorders
Terminal agitation
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
11/59 • Number of events 14 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
29.5%
23/78 • Number of events 29 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.5%
7/56 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
25.4%
16/63 • Number of events 20 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
26.1%
43/165 • Number of events 55 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
6.8%
4/59 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
15.4%
12/78 • Number of events 15 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.5%
7/56 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.7%
8/63 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
17/165 • Number of events 30 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
16.7%
2/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
28.6%
2/7 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.6%
11/59 • Number of events 18 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.1%
11/78 • Number of events 15 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
17.9%
10/56 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
19.0%
12/63 • Number of events 17 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
33.3%
3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.7%
11/165 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.2%
6/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.1%
4/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.3%
9/59 • Number of events 11 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.5%
7/56 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.7%
8/63 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
44.4%
4/9 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.9%
18/165 • Number of events 23 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.1%
10/165 • Number of events 26 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
16.7%
2/12 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Tumour pruritus
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.8%
4/59 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.6%
8/59 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.1%
4/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
13.3%
22/165 • Number of events 23 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.1%
3/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.7%
6/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.3%
4/63 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.3%
4/63 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
5/63 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.3%
12/59 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.1%
11/78 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
17.9%
10/56 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
17.5%
11/63 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.5%
24/165 • Number of events 32 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
5/59 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.7%
6/56 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.7%
16/165 • Number of events 17 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
16.7%
2/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.7%
6/78 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
4/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.7%
11/165 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
4/59 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
8.5%
5/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.8%
10/78 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.3%
12/165 • Number of events 15 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.8%
4/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.7%
6/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.1%
4/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.3%
12/165 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Blood creatinine increased
|
6.8%
4/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.9%
5/56 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
28.6%
2/7 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Lymphocyte count decreased
|
6.8%
4/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
11/59 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
20.5%
16/78 • Number of events 18 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.9%
5/56 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.2%
6/59 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.7%
6/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.7%
11/165 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.2%
6/59 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.5%
5/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.5%
5/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
6/59 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.5%
9/78 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.9%
5/56 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.7%
8/63 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
33.3%
3/9 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Wound infection
|
6.8%
4/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection
|
10.2%
6/59 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 11 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
5/63 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Skin infection
|
6.8%
4/59 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.1%
10/165 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
13/165 • Number of events 14 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
33.3%
4/12 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.3%
4/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Nail infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
5/59 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Oral candidiasis
|
8.5%
5/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
5/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.9%
7/59 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
8/56 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.7%
8/63 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.7%
11/165 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.1%
3/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.8%
10/78 • Number of events 15 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.5%
6/63 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.5%
14/165 • Number of events 32 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
16.7%
2/12 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
28.6%
2/7 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.3%
12/165 • Number of events 25 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
8.5%
5/59 • Number of events 10 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.1%
10/165 • Number of events 19 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
16.7%
2/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Headache
|
18.6%
11/59 • Number of events 12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.1%
15/165 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Dizziness
|
13.6%
8/59 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.4%
5/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
5/63 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.9%
13/165 • Number of events 13 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Dysgeusia
|
6.8%
4/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Memory impairment
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.1%
4/56 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Hypothyroidism
|
10.2%
6/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.5%
9/78 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
12.5%
7/56 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
22.2%
2/9 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.5%
14/165 • Number of events 15 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Eye disorders
Eye swelling
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Eye disorders
Dry eye
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
8.5%
5/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.1%
4/56 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.3%
4/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.5%
14/165 • Number of events 16 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
16.7%
2/12 • Number of events 2 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.1%
4/78 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
6.3%
4/63 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.8%
4/59 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
10.3%
8/78 • Number of events 8 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.5%
9/165 • Number of events 9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
5.4%
3/56 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Psychiatric disorders
Depression
|
8.5%
5/59 • Number of events 5 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Hypertension
|
10.2%
6/59 • Number of events 6 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
9.0%
7/78 • Number of events 11 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.3%
12/165 • Number of events 18 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
7.1%
4/56 • Number of events 4 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Vascular disorders
Lymphoedema
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
14.3%
1/7 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
1/9 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
11.1%
7/63 • Number of events 7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/12 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Renal failure
|
5.1%
3/59 • Number of events 3 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/59 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/78 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/56 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/63 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/9 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/165 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
8.3%
1/12 • Number of events 1 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
0.00%
0/7 • From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER