Trial Outcomes & Findings for SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis (NCT NCT03136861)
NCT ID: NCT03136861
Last Updated: 2021-09-05
Results Overview
The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. It is an 11-point scale from 0-10: 1) "0" = no pain. 2) "10" = the most intense pain imaginable. To calculate the average spinal pain, the patient was asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
383 participants
Primary outcome timeframe
Week 8
Results posted on
2021-09-05
Participant Flow
This study was conducted at 66 centers in 17 countries worldwide: Spain(14), Czech Republic(3), Finland(2), Lithuania(2), Estonia(3), Latvia(3), Switzerland(1), Russia(4), Sweden(4), United Kingdom(5), Belgium(2), Ireland(2), Poland(7), Croatia(3), Bulgaria(5), Greece(5), Italy(1).
At Baseline, patients were randomized to either secukinumab 150 mg or placebo (Group A or B). At Week 8, patients were re-randomized or re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg (Arm A1 to B2).
Participant milestones
| Measure |
Secukinumab 150 mg (Group A)
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
Arm A1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A2
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A3
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Arm B1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm B2
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
STARTED
|
285
|
95
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
COMPLETED
|
278
|
89
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
NOT COMPLETED
|
7
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (TP2) (Wk 8-Wk 24)
STARTED
|
0
|
0
|
90
|
94
|
94
|
45
|
44
|
|
Treatment Period 2 (TP2) (Wk 8-Wk 24)
COMPLETED
|
0
|
0
|
88
|
93
|
92
|
45
|
43
|
|
Treatment Period 2 (TP2) (Wk 8-Wk 24)
NOT COMPLETED
|
0
|
0
|
2
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Secukinumab 150 mg (Group A)
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
Arm A1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A2
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A3
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Arm B1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm B2
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
|---|---|---|---|---|---|---|---|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
Adverse Event
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
Protocol Deviation
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
Subject/Guardian Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (TP1)(Baseline-Wk 8)
Withdrawal of Informed Consent
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (TP2) (Wk 8-Wk 24)
Adverse Event
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
|
Treatment Period 2 (TP2) (Wk 8-Wk 24)
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (TP2) (Wk 8-Wk 24)
Withdrawal of Informed Consent
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
Baseline characteristics by cohort
| Measure |
Secukinumab 150 mg (Group A)
n=285 Participants
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
n=95 Participants
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
Arm A1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A2
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A3
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Arm B1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm B2
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 11.88 • n=5 Participants
|
40.9 Years
STANDARD_DEVIATION 12.20 • n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
42.0 Years
STANDARD_DEVIATION 11.96 • n=24 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
145 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
235 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
267 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
360 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
17 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) in Treatment Period 1.
The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. It is an 11-point scale from 0-10: 1) "0" = no pain. 2) "10" = the most intense pain imaginable. To calculate the average spinal pain, the patient was asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.
Outcome measures
| Measure |
Secukinumab 150 mg (Group A)
n=279 Participants
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
n=92 Participants
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
|---|---|---|
|
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Total Spinal Pain Score · Yes
|
77 Participants
|
17 Participants
|
|
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Total Spinal Pain Score · No
|
202 Participants
|
75 Participants
|
|
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Nocturnal Spinal Pain Score · Yes
|
92 Participants
|
16 Participants
|
|
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Nocturnal Spinal Pain Score · No
|
187 Participants
|
76 Participants
|
|
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Average Spinal Pain Score · Yes
|
91 Participants
|
19 Participants
|
|
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Average Spinal Pain Score · No
|
188 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS) in Treatment Period 1.
The Bath ankylosing spondylitis disease activity index (BASDAI) consists of a 0 through 10 scale, which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.
Outcome measures
| Measure |
Secukinumab 150 mg (Group A)
n=280 Participants
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
n=92 Participants
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
|---|---|---|
|
Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
No (n=185,70)
|
185 Participants
|
70 Participants
|
|
Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
Yes (n=95,22)
|
95 Participants
|
22 Participants
|
Adverse Events
Secukinumab 150 mg (Group A)
Serious events: 4 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo (Group B)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm A1
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm A2
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Arm A3
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm B1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm B2
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 150 mg (Group A)
n=285 participants at risk
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
n=95 participants at risk
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
Arm A1
n=90 participants at risk
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A2
n=94 participants at risk
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A3
n=94 participants at risk
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Arm B1
n=45 participants at risk
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm B2
n=44 participants at risk
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Cardiac disorders
Myocardial infarction
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Anal abscess
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Renal and urinary disorders
Renal mass
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
Other adverse events
| Measure |
Secukinumab 150 mg (Group A)
n=285 participants at risk
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
|
Placebo (Group B)
n=95 participants at risk
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
|
Arm A1
n=90 participants at risk
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A2
n=94 participants at risk
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm A3
n=94 participants at risk
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Arm B1
n=45 participants at risk
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
|
Arm B2
n=44 participants at risk
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Eye disorders
Blepharitis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Eye disorders
Iritis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
6/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
General disorders
Fatigue
|
2.1%
6/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
General disorders
Injection site pain
|
0.70%
2/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
2/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Herpes simplex
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
6/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
4.3%
4/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
4.4%
2/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
4.5%
2/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Otitis externa
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Pharyngitis
|
1.1%
3/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
2/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Rhinitis
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
2/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
4/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
5.3%
5/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
2/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Investigations
Alanine aminotransferase increased
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Investigations
Blood creatinine increased
|
1.4%
4/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.3%
3/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
4.5%
2/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
4/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
6/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Nervous system disorders
Headache
|
3.5%
10/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
2/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Renal and urinary disorders
Haematuria
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.2%
3/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Renal and urinary disorders
Proteinuria
|
1.1%
3/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.70%
2/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
3.3%
3/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
8/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
4.4%
4/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.35%
1/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.1%
2/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.70%
2/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.2%
1/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
|
Vascular disorders
Hypertension
|
1.1%
3/285 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
1.1%
1/95 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/90 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/94 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
0.00%
0/45 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
2.3%
1/44 • Treatment emergent adverse events were collected from first dose of study treatment until end of study treatment plus 12 weeks, up to a maximum duration of 32 weeks.
Any sign or symptom that occurs after written informed consent provided. Treatment emergent adverse events were reported until end of study treatment plus 12 weeks post treatment. Treatment emergent adverse events occurring during Treatment Period 1 are recorded in Group A and B arms. Treatment emergent adverse events occurring during Treatment Period 2 are recorded in Arm A1 to Arm B2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER