Trial Outcomes & Findings for Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients (NCT NCT03656562)
NCT ID: NCT03656562
Last Updated: 2026-05-14
Results Overview
The primary endpoint was a composite of SRI-4 response at Week 29 with sustained reduction in oral corticosteroid from Week 17 through Week 29. Patients taking other rescue medication or prohibited medication or drop out before Week 29 were considered non-responders. SRI-4 response is defined as below: * having \>= 4 points reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (score is 0 to 105; a higher score indicating more severe disease) AND * no new British Isles Lupus Activity Group (BILAG)-2004 A organ domain score and no more than one new BILAG-2004 B organ domain scores compared with baseline AND * \<10 mm point increase from baseline with scale 0 to 100 mm in the physician's global assessment from baseline Sustained reduction in oral corticosteroid is defined as below: * =\< 5 mg/day or less than or equal to baseline dose, whichever was lower at Week 17 AND * no increase of that dose from Week 17 through Week 29
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Baseline, Week 17 to Week 29
Results posted on
2026-05-14
Participant Flow
This study was conducted in 31 centers in 15 countries: Argentina (1), Australia (1), China (3), Czech Republic (1), France (1), Germany (2), Hungary (2), Israel (1), Japan (5), Korea, Republic of (1), Poland (3), Russia (3), Spain (2), Taiwan (3), Thailand (2).
Participant milestones
| Measure |
Cohort 1 VAY736
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
20
|
20
|
|
Overall Study
Pharmacodynamic Analysis Set
|
34
|
33
|
20
|
20
|
|
Overall Study
Safety Set
|
34
|
33
|
20
|
20
|
|
Overall Study
Pharmacokinetic Analysis Set
|
34
|
30
|
20
|
16
|
|
Overall Study
COMPLETED
|
26
|
21
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 VAY736
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
5
|
0
|
0
|
|
Overall Study
Subject Decision
|
5
|
7
|
0
|
3
|
Baseline Characteristics
Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
Baseline characteristics by cohort
| Measure |
Cohort 1 VAY736
n=34 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=33 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=20 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=20 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
0 Participants
n=99 Participants
|
1 Participants
n=97 Participants
|
|
Age, Continuous
|
42.0 Years
STANDARD_DEVIATION 10.91 • n=1512 Participants
|
39.2 Years
STANDARD_DEVIATION 10.46 • n=504 Participants
|
37.4 Years
STANDARD_DEVIATION 11.34 • n=2016 Participants
|
44.7 Years
STANDARD_DEVIATION 12.47 • n=99 Participants
|
40.8 Years
STANDARD_DEVIATION 11.29 • n=97 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=1512 Participants
|
27 Participants
n=504 Participants
|
20 Participants
n=2016 Participants
|
19 Participants
n=99 Participants
|
98 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
1 Participants
n=99 Participants
|
9 Participants
n=97 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=1512 Participants
|
12 Participants
n=504 Participants
|
7 Participants
n=2016 Participants
|
12 Participants
n=99 Participants
|
40 Participants
n=97 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=1512 Participants
|
21 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
8 Participants
n=99 Participants
|
66 Participants
n=97 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 17 to Week 29Population: Pharmacodynamic analysis set (PD analysis set)
The primary endpoint was a composite of SRI-4 response at Week 29 with sustained reduction in oral corticosteroid from Week 17 through Week 29. Patients taking other rescue medication or prohibited medication or drop out before Week 29 were considered non-responders. SRI-4 response is defined as below: * having \>= 4 points reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (score is 0 to 105; a higher score indicating more severe disease) AND * no new British Isles Lupus Activity Group (BILAG)-2004 A organ domain score and no more than one new BILAG-2004 B organ domain scores compared with baseline AND * \<10 mm point increase from baseline with scale 0 to 100 mm in the physician's global assessment from baseline Sustained reduction in oral corticosteroid is defined as below: * =\< 5 mg/day or less than or equal to baseline dose, whichever was lower at Week 17 AND * no increase of that dose from Week 17 through Week 29
Outcome measures
| Measure |
Cohort 1 VAY736
n=34 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=33 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=20 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=20 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Percentage of Participants With SLE Responder Index (SRI)-4 Response Status at Week 29 With Reduced Steroid Dose Maintained Between Weeks 17 and 29
|
15 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29Population: Pharmacodynamic analysis set (PD analysis set). Only participants with a value at both Baseline and post-baseline visit included.
The Physician's global assessment (PhGA-VAS) of disease activity was performed using 100 mm VAS ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.
Outcome measures
| Measure |
Cohort 1 VAY736
n=34 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=33 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=20 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=20 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 17 n=34,31,20,19
|
-26.2 Unit on a scale
Standard Deviation 19.14
|
-14.2 Unit on a scale
Standard Deviation 16.38
|
-21.9 Unit on a scale
Standard Deviation 21.81
|
-22.2 Unit on a scale
Standard Deviation 20.10
|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 21 n=34,33,19,18
|
-28.1 Unit on a scale
Standard Deviation 20.27
|
-17.9 Unit on a scale
Standard Deviation 16.24
|
-26.1 Unit on a scale
Standard Deviation 23.15
|
-24.1 Unit on a scale
Standard Deviation 17.71
|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 5 n=34,33,20,20
|
-7.6 Unit on a scale
Standard Deviation 14.27
|
-5.6 Unit on a scale
Standard Deviation 13.76
|
-8.3 Unit on a scale
Standard Deviation 12.04
|
-12.5 Unit on a scale
Standard Deviation 15.94
|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 9 n=33,33,20,19
|
-17.4 Unit on a scale
Standard Deviation 18.72
|
-10.9 Unit on a scale
Standard Deviation 13.54
|
-9.3 Unit on a scale
Standard Deviation 15.73
|
-13.7 Unit on a scale
Standard Deviation 18.43
|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 13 n=33,33,20,19
|
-23.0 Unit on a scale
Standard Deviation 19.51
|
-13.6 Unit on a scale
Standard Deviation 16.72
|
-19.4 Unit on a scale
Standard Deviation 16.70
|
-20.3 Unit on a scale
Standard Deviation 19.26
|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 25 n=33,32,19,18
|
-33.2 Unit on a scale
Standard Deviation 19.63
|
-18.6 Unit on a scale
Standard Deviation 17.62
|
-28.5 Unit on a scale
Standard Deviation 22.92
|
-24.6 Unit on a scale
Standard Deviation 19.12
|
|
Changes Between Baseline and Week 29 in the Physicians' Global Assessment (PhGA) Visual Analog Scale (VAS) Assessing Patient's Overall Disease Activity
Week 29 n=33,32,20,17
|
-32.8 Unit on a scale
Standard Deviation 20.74
|
-19.4 Unit on a scale
Standard Deviation 16.04
|
-28.7 Unit on a scale
Standard Deviation 22.89
|
-24.5 Unit on a scale
Standard Deviation 19.25
|
SECONDARY outcome
Timeframe: Baseline, Week 5, Week 9, Week 13, Week 17, Week 21, Week 25, Week 29Population: Pharmacodynamic analysis set (PD analysis set). Only participants with a value at both Baseline and post-baseline visit included.
The patient's global assessment of disease activity was performed using a Visual Analogue Scale (VAS) of 100 mm ranging from "no disease activity" (score 0) to "severe disease activity" (score 100), after the question on how well the patient was doing with the disease considering all aspects affected by the disease. The investigator was then measuring the distance in mm from the left edge of the scale and entering the value.
Outcome measures
| Measure |
Cohort 1 VAY736
n=34 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=33 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=20 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=20 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 5 n=34,32,20,20
|
-9.0 Unit on a scale
Standard Deviation 23.14
|
-4.8 Unit on a scale
Standard Deviation 13.60
|
-9.8 Unit on a scale
Standard Deviation 20.63
|
-3.8 Unit on a scale
Standard Deviation 19.33
|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 9 n=33,33,20,19
|
-12.5 Unit on a scale
Standard Deviation 21.35
|
-12.2 Unit on a scale
Standard Deviation 15.62
|
-17.9 Unit on a scale
Standard Deviation 30.22
|
0.1 Unit on a scale
Standard Deviation 20.52
|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 13 n=32,33,20,19
|
-15.7 Unit on a scale
Standard Deviation 21.69
|
-8.8 Unit on a scale
Standard Deviation 17.75
|
-21.8 Unit on a scale
Standard Deviation 31.01
|
-0.1 Unit on a scale
Standard Deviation 22.10
|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 17 n=34,31,20,19
|
-12.7 Unit on a scale
Standard Deviation 24.19
|
-8.0 Unit on a scale
Standard Deviation 19.27
|
-26.7 Unit on a scale
Standard Deviation 28.92
|
1.6 Unit on a scale
Standard Deviation 19.05
|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 21 n=34,32,19,18
|
-15.1 Unit on a scale
Standard Deviation 24.82
|
-9.5 Unit on a scale
Standard Deviation 24.88
|
-27.2 Unit on a scale
Standard Deviation 31.92
|
-0.5 Unit on a scale
Standard Deviation 24.79
|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 25 n=33,32,19,18
|
-18.0 Unit on a scale
Standard Deviation 19.91
|
-10.4 Unit on a scale
Standard Deviation 21.33
|
-27.0 Unit on a scale
Standard Deviation 30.58
|
1.1 Unit on a scale
Standard Deviation 25.62
|
|
Changes Between Baseline and Week 29 in the Patient's Global Assessment (PGA) Visual Analog Scale (VAS) Assessing Patient's Global Disease Activity
Week 29 n=33,32,20,17
|
-18.1 Unit on a scale
Standard Deviation 21.81
|
-9.0 Unit on a scale
Standard Deviation 24.64
|
-27.8 Unit on a scale
Standard Deviation 33.41
|
-1.9 Unit on a scale
Standard Deviation 25.06
|
SECONDARY outcome
Timeframe: Up to 69 weeksPopulation: Pharmacodynamic analysis set (PD analysis set)
Flare was defined as one new 'A' score or two or more 'B' scores using the British Isles Lupus Assessment Group Index (BILAG -2004).
Outcome measures
| Measure |
Cohort 1 VAY736
n=34 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=33 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=20 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=20 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Percentage of Participants With Flare
Open-label Treatment n=33,32,20,16
|
0 percentage of participants
|
9.4 percentage of participants
|
10 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Flare
Post-treatment Follow-up n=32,30,20,16
|
3.1 percentage of participants
|
3.3 percentage of participants
|
5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Flare
Double-blind Treatment (<=29 Weeks) n=34,33,20,20
|
8.8 percentage of participants
|
30.3 percentage of participants
|
20 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 69 weeksPopulation: PD analysis set. Number analyzed is the number of patients with data available at the specified time point.
Time to first flare, with flare defined as one new 'A' score or two or more 'B' score using BILAG -2004
Outcome measures
| Measure |
Cohort 1 VAY736
n=3 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=10 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=4 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=2 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Time to First Flare
Double-blind Treatment (<=29 Weeks) n=3,10,4,2
|
94.7 days
Standard Deviation 89.80
|
107.7 days
Standard Deviation 34.23
|
113.0 days
Standard Deviation 68.61
|
69.0 days
Standard Deviation 19.80
|
|
Time to First Flare
Open-label Treatment n=0,3,2,0
|
—
|
301.3 days
Standard Deviation 17.79
|
379.0 days
Standard Deviation 11.31
|
—
|
|
Time to First Flare
Post-treatment Follow-up n=1,1,1,0
|
419.0 days
Standard Deviation NA
Not calculable due to the single data point.
|
484.0 days
Standard Deviation NA
Not calculable due to the single data point.
|
421.0 days
Standard Deviation NA
Not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Weeks 29, 53, 69, and EoS (up to 69 weeks), pre-dosePopulation: PK analysis set. Number analyzed is the number of patients with data available at the specified time point.
Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.
Outcome measures
| Measure |
Cohort 1 VAY736
n=29 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=26 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration
Week 69 n=26,23
|
0.03 μg/mL
Standard Deviation 0.14
|
0 μg/mL
Standard Deviation 0
|
—
|
—
|
|
Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration
EoS n=13,13
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
—
|
—
|
|
Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration
Week 53 n=22,23
|
1.68 μg/mL
Standard Deviation 1.30
|
2.24 μg/mL
Standard Deviation 1.45
|
—
|
—
|
|
Pharmacokinetics (PK) Cohort 1 - VAY736 Free Serum Concentration
Week 29 n=29,26
|
1.85 μg/mL
Standard Deviation 1.17
|
0 μg/mL
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 29, 53, and 69, pre-dosePopulation: PK analysis set. Number analyzed is the number of patients with data available at the specified time point.
Outcome measures
| Measure |
Cohort 1 VAY736
n=20 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=11 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
PK Cohort 2 - Free CFZ533 Concentration in Plasma
Week 29 n=20,7
|
59.9 μg/mL
Standard Deviation 40.3
|
0 μg/mL
Standard Deviation 0
|
—
|
—
|
|
PK Cohort 2 - Free CFZ533 Concentration in Plasma
Week 53 n=20,9
|
56.9 μg/mL
Standard Deviation 39.6
|
42.5 μg/mL
Standard Deviation 20
|
—
|
—
|
|
PK Cohort 2 - Free CFZ533 Concentration in Plasma
Week 69 n=18,11
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 29, 53, and 69Population: PD analysis set
Outcome measures
| Measure |
Cohort 1 VAY736
n=20 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=20 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
PD Cohort 2 (CFZ533): Total Soluble CD40
Week 29
|
143 ng/mL
Standard Deviation 44.4
|
0.365 ng/mL
Standard Deviation 0.504
|
—
|
—
|
|
PD Cohort 2 (CFZ533): Total Soluble CD40
Week 53
|
158 ng/mL
Standard Deviation 36.1
|
124 ng/mL
Standard Deviation 67
|
—
|
—
|
|
PD Cohort 2 (CFZ533): Total Soluble CD40
Week 69
|
3 ng/mL
Standard Deviation 3.89
|
1.38 ng/mL
Standard Deviation 0.892
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 29, 53, 69, and EoS (up to 69 weeks)Population: Safety set. Number analyzed is the number of patients with data available at the specified time point.
ADAs were measured in plasma for CFZ533 and in serum for VAY736. Note: End of study (EoS) was a floating timepoint and did not represent a uniform timepoint across the study.
Outcome measures
| Measure |
Cohort 1 VAY736
n=30 Participants
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 1 VAY736 Placebo
n=30 Participants
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
Cohort 2 CFZ533
n=20 Participants
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Cohort 2 CFZ533 Placebo
n=17 Participants
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-drug Antibodies (ADAs)
Baseline n=30,29,19,17
|
26.5 percentage of participants
|
21.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-drug Antibodies (ADAs)
Week 29 n=30,30,20,17
|
5.9 percentage of participants
|
21.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-drug Antibodies (ADAs)
Week 53 n=29,28,20,15
|
0 percentage of participants
|
6.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-drug Antibodies (ADAs)
Week 69 n=26,28,18,14
|
9.4 percentage of participants
|
13.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Anti-drug Antibodies (ADAs)
EoS n=19,16,0,0
|
11.8 percentage of participants
|
9.1 percentage of participants
|
—
|
—
|
Adverse Events
VAY736 Placebo
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
VAY736
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
CFZ533
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
CFZ533 Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Total (Double-blind)
Serious events: 6 serious events
Other events: 62 other events
Deaths: 0 deaths
VAY736/VAY736
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
VAY736 Placebo/VAY736
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
CFZ533/CFZ533
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
CFZ533 Placebo/CFZ533
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Total (Open-label)
Serious events: 6 serious events
Other events: 57 other events
Deaths: 0 deaths
VAY736/VAY736 (Post-treatment Follow-up)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
VAY736 Placebo/VAY736 (Post-treatment Follow-up)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CFZ533/CFZ533 (Post-treatment Follow-up)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Total (Post-treatment Follow-up)
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
VAY736/VAY736 (Secondary Post-treatment Follow-up)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Total (Secondary Post-treatment Follow-up)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAY736 Placebo
n=33 participants at risk
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
VAY736
n=34 participants at risk
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
CFZ533
n=20 participants at risk
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
CFZ533 Placebo
n=20 participants at risk
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
Total (Double-blind)
n=107 participants at risk
Total (Double-blind)
|
VAY736/VAY736
n=33 participants at risk
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
VAY736 Placebo/VAY736
n=32 participants at risk
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
CFZ533/CFZ533
n=20 participants at risk
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
CFZ533 Placebo/CFZ533
n=16 participants at risk
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Total (Open-label)
n=101 participants at risk
Total (Open-label)
|
VAY736/VAY736 (Post-treatment Follow-up)
n=32 participants at risk
Post-treatment follow-up
|
VAY736 Placebo/VAY736 (Post-treatment Follow-up)
n=30 participants at risk
Post-treatment follow-up
|
CFZ533/CFZ533 (Post-treatment Follow-up)
n=20 participants at risk
Post-treatment follow-up
|
CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)
n=16 participants at risk
Post-treatment follow-up
|
Total (Post-treatment Follow-up)
n=98 participants at risk
Total (post-treatment follow-up)
|
VAY736/VAY736 (Secondary Post-treatment Follow-up)
n=29 participants at risk
Secondary post-treatment follow-up
|
VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)
n=25 participants at risk
Secondary post-treatment follow-up
|
Total (Secondary Post-treatment Follow-up)
n=54 participants at risk
Total (secondary post-treatment follow-up)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Herpes zoster
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Pyelonephritis
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Salmonella bacteraemia
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Nervous system disorders
Central nervous system vasculitis
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
Other adverse events
| Measure |
VAY736 Placebo
n=33 participants at risk
Blinded treatment phase:
VAY736 matching placebo administered subcutaneously (s.c.) every 4 weeks as multiple doses of placebo 0 mg until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
VAY736
n=34 participants at risk
Blinded treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
CFZ533
n=20 participants at risk
Blinded treatment phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
CFZ533 Placebo
n=20 participants at risk
Blinded treatment phase:
CFZ533 matching placebo administered intravenously (i.v) every 4 weeks as multiple doses of placebo 0 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 25 + Standard of Care (SoC) for systemic lupus erythematosus (SLE).
|
Total (Double-blind)
n=107 participants at risk
Total (Double-blind)
|
VAY736/VAY736
n=33 participants at risk
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
VAY736 Placebo/VAY736
n=32 participants at risk
Open-label treatment phase:
VAY736 administered subcutaneously (s.c.) every 4 weeks as multiple doses of VAY736 150 mg (total dose being VAY736 300 mg) until Week 49.
|
CFZ533/CFZ533
n=20 participants at risk
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
CFZ533 Placebo/CFZ533
n=16 participants at risk
Open-label phase:
CFZ533 administered intravenously (i.v) every 4 weeks as multiple doses of CFZ533 150 mg, based on body weight (BW) of the patients (10 mg/kg (\>= 50 kg BW) and 13 mg/kg (\< 50 kg BW)) until Week 49.
|
Total (Open-label)
n=101 participants at risk
Total (Open-label)
|
VAY736/VAY736 (Post-treatment Follow-up)
n=32 participants at risk
Post-treatment follow-up
|
VAY736 Placebo/VAY736 (Post-treatment Follow-up)
n=30 participants at risk
Post-treatment follow-up
|
CFZ533/CFZ533 (Post-treatment Follow-up)
n=20 participants at risk
Post-treatment follow-up
|
CFZ533 Placebo/CFZ533 (Post-treatment Follow-up)
n=16 participants at risk
Post-treatment follow-up
|
Total (Post-treatment Follow-up)
n=98 participants at risk
Total (post-treatment follow-up)
|
VAY736/VAY736 (Secondary Post-treatment Follow-up)
n=29 participants at risk
Secondary post-treatment follow-up
|
VAY736 Placebo/VAY736 (Secondary Post-treatment Follow-up)
n=25 participants at risk
Secondary post-treatment follow-up
|
Total (Secondary Post-treatment Follow-up)
n=54 participants at risk
Total (secondary post-treatment follow-up)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Eye disorders
Cataract
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Eye disorders
Dry eye
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
12.5%
2/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.7%
5/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
General disorders
Injection site reaction
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
26.5%
9/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
9.3%
10/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
18.2%
6/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
37.5%
12/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
17.8%
18/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
General disorders
Pyrexia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.7%
4/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Bronchitis
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
COVID-19
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
4/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.3%
3/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
7.4%
4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Cellulitis
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Cystitis
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Herpes zoster
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Nasopharyngitis
|
21.2%
7/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
20.6%
7/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
17.8%
19/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
15.2%
5/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
20.0%
4/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
18.8%
3/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
12.9%
13/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
3/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
13.8%
4/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
9.3%
5/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
8.8%
3/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.5%
7/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.7%
5/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
4/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Investigations
Blood immunoglobulin M decreased
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
9.1%
3/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.1%
2/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.4%
1/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.7%
4/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
8.8%
3/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
25.0%
5/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
9.3%
10/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.1%
1/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.9%
2/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.9%
1/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
9.4%
3/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.8%
3/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
2/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.3%
1/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.0%
1/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.93%
1/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
3.0%
1/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.7%
2/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
2.0%
2/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
4.0%
1/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
6.2%
1/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
5.9%
2/34 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
1.9%
2/107 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/33 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/32 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/30 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/16 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/98 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/29 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/25 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus up to 2 years post treatment, up to a maximum duration of approximately 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER