Trial Outcomes & Findings for This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (NCT NCT03713619)
NCT ID: NCT03713619
Last Updated: 2024-10-09
Results Overview
HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
544 participants
Primary outcome timeframe
16 weeks
Results posted on
2024-10-09
Participant Flow
Participants were enrolled in 111 study sites worldwide.
Participant milestones
| Measure |
Secukinumab - Q2W
Secukinumab 300mg every 2 weeks (Treatment Period 1 and 2)
|
Secukinumab - Q4W
Secukinumab 300mg every 4 weeks (Treatment Period 1 and 2)
|
Placebo
Placebo group to secukinumab 300mg (Treatment Period 1)
|
Placebo - Re-randomized to Secukinumab Q2W
Placebo group, re-randomized to secukinumab 300mg Q2W at week 16 (Treatment Period 2)
|
Placebo - Re-randomized to Secukinumab Q4W
Placebo group, re-randomized to secukinumab 300mg Q4W at week 16 (Treatment Period 2)
|
|---|---|---|---|---|---|
|
Treatment Period 1 (Until Week 16)
STARTED
|
182
|
181
|
181
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Full Analysis Set (FAS)
|
181
|
180
|
180
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
COMPLETED
|
168
|
169
|
172
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
NOT COMPLETED
|
14
|
12
|
9
|
0
|
0
|
|
Treatment Period 2 (After Week 16)
STARTED
|
168
|
169
|
0
|
85
|
87
|
|
Treatment Period 2 (After Week 16)
COMPLETED
|
131
|
137
|
0
|
68
|
75
|
|
Treatment Period 2 (After Week 16)
NOT COMPLETED
|
37
|
32
|
0
|
17
|
12
|
Reasons for withdrawal
| Measure |
Secukinumab - Q2W
Secukinumab 300mg every 2 weeks (Treatment Period 1 and 2)
|
Secukinumab - Q4W
Secukinumab 300mg every 4 weeks (Treatment Period 1 and 2)
|
Placebo
Placebo group to secukinumab 300mg (Treatment Period 1)
|
Placebo - Re-randomized to Secukinumab Q2W
Placebo group, re-randomized to secukinumab 300mg Q2W at week 16 (Treatment Period 2)
|
Placebo - Re-randomized to Secukinumab Q4W
Placebo group, re-randomized to secukinumab 300mg Q4W at week 16 (Treatment Period 2)
|
|---|---|---|---|---|---|
|
Treatment Period 1 (Until Week 16)
Adverse Event
|
4
|
0
|
1
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Lost to Follow-up
|
3
|
1
|
1
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Physician Decision
|
1
|
1
|
1
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Technical problems
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Withdrawal by Subject
|
4
|
9
|
5
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Misrandomized
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1 (Until Week 16)
Severe GCP Violation
|
1
|
1
|
0
|
0
|
0
|
|
Treatment Period 2 (After Week 16)
Adverse Event
|
6
|
5
|
0
|
1
|
2
|
|
Treatment Period 2 (After Week 16)
Pregnancy
|
1
|
0
|
0
|
1
|
0
|
|
Treatment Period 2 (After Week 16)
Withdrawal by Subject
|
26
|
20
|
0
|
10
|
6
|
|
Treatment Period 2 (After Week 16)
Poor efficacy
|
1
|
2
|
0
|
2
|
1
|
|
Treatment Period 2 (After Week 16)
Lost to Follow-up
|
3
|
3
|
0
|
2
|
2
|
|
Treatment Period 2 (After Week 16)
Physician Decision
|
0
|
2
|
0
|
1
|
1
|
Baseline Characteristics
This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
Baseline characteristics by cohort
| Measure |
Secukinumab 1 - Q2W
n=181 Participants
Secukinumab 300mg every 2 weeks
|
Secukinumab 2 - Q4W
n=180 Participants
Secukinumab 300mg every 4 weeks
|
Placebo
n=180 Participants
Placebo group to secukinumab 300mg every 4 weeks
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
178 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
534 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 12.53 • n=99 Participants
|
35.7 years
STANDARD_DEVIATION 11.71 • n=107 Participants
|
35.5 years
STANDARD_DEVIATION 10.75 • n=206 Participants
|
36.1 years
STANDARD_DEVIATION 11.69 • n=7 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
304 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
237 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
145 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
430 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Full analysis set (FAS)
HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression.
Outcome measures
| Measure |
Secukinumab 1 - Q2W
n=181 Participants
Secukinumab 300mg every 2 weeks
|
Secukinumab 2 - Q4W
n=180 Participants
Secukinumab 300mg every 4 weeks
|
Placebo
n=180 Participants
Placebo group to secukinumab 300mg
|
|---|---|---|---|
|
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)
|
45.0 Percentage of participants
|
41.8 Percentage of participants
|
33.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: FAS
The HS affected areas, e.g. right and left axillary (armpit), right and left gluteal ("buttock"), right and left inguinal-femoral (groin), perineal, pubic, sternal, right and left sub-mammary (breast) and others were assessed by the physician for abscesses, inflammatory nodules, draining fistulas, total fistulas, and other lesions. Inflammatory lesions, including abscesses, nodules, draining fistulae, total fistulae and other lesions were counted. The analysis method for percentage change from baseline in abscesses and inflammatory nodules (AN) count at Week 16 was an ANCOVA model.
Outcome measures
| Measure |
Secukinumab 1 - Q2W
n=181 Participants
Secukinumab 300mg every 2 weeks
|
Secukinumab 2 - Q4W
n=180 Participants
Secukinumab 300mg every 4 weeks
|
Placebo
n=180 Participants
Placebo group to secukinumab 300mg
|
|---|---|---|---|
|
Percentage Change From Baseline in AN50 Count at Week 16
|
-46.8 percentage change from baseline
Standard Error 3.33
|
-42.4 percentage change from baseline
Standard Error 4.01
|
-24.3 percentage change from baseline
Standard Error 4.33
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS
Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline. This endpoint was analyzed by logistic regression.
Outcome measures
| Measure |
Secukinumab 1 - Q2W
n=181 Participants
Secukinumab 300mg every 2 weeks
|
Secukinumab 2 - Q4W
n=180 Participants
Secukinumab 300mg every 4 weeks
|
Placebo
n=180 Participants
Placebo group to secukinumab 300mg
|
|---|---|---|---|
|
Percentage of Participants With Hidradenitis Suppurativa (HS) Flares
|
15.4 Percentage of participants
|
23.2 Percentage of participants
|
29.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, week 16Population: FAS restricted to participants with baseline NRS score greater or equal to 3
Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 \[no skin pain\] to 10 \[worst skin pain\]). This endpoint was analyzed by logistic regression.
Outcome measures
| Measure |
Secukinumab 1 - Q2W
n=131 Participants
Secukinumab 300mg every 2 weeks
|
Secukinumab 2 - Q4W
n=123 Participants
Secukinumab 300mg every 4 weeks
|
Placebo
n=119 Participants
Placebo group to secukinumab 300mg
|
|---|---|---|---|
|
Percentage of Participants Achieving NRS30
|
34.1 Percentage of participants
|
32.2 Percentage of participants
|
23.8 Percentage of participants
|
Adverse Events
AIN457 Q2W
Serious events: 13 serious events
Other events: 135 other events
Deaths: 0 deaths
AIN457 Q4W
Serious events: 9 serious events
Other events: 132 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 88 other events
Deaths: 0 deaths
Any AIN457 Q2W
Serious events: 18 serious events
Other events: 184 other events
Deaths: 0 deaths
Any AIN457 Q4W
Serious events: 19 serious events
Other events: 183 other events
Deaths: 0 deaths
Any AIN457
Serious events: 37 serious events
Other events: 367 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 Q2W
n=181 participants at risk
Subjects who were randomized to AIN457 (secukinumab) 300mg Q2W dose regimen at the study entry. Adverse events were assessed up to Week 60
|
AIN457 Q4W
n=180 participants at risk
Subjects who were randomized to AIN457 (secukinumab) 300mg Q4W dose regimen at the study entry. Adverse events were assessed up to Week 60
|
Placebo
n=180 participants at risk
Subjects received matching placebo up to 16 weeks
|
Any AIN457 Q2W
n=266 participants at risk
Subjects who received at least 1 dose of secukinumab 300 mg Q2W dose (e.g., subjects who switched from placebo to secukinumab Q2W at Week 16). Adverse events were assessed up to Week 60
|
Any AIN457 Q4W
n=267 participants at risk
Subjects who received at least 1 dose of secukinumab 300 mg Q4W dose (e.g., subjects who switched from placebo to secukinumab Q4W at Week 16). Adverse events were assessed up to Week 60
|
Any AIN457
n=533 participants at risk
Subjects who received at least 1 dose of secukinumab
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Fatigue
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Pyrexia
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
2/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
COVID-19
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
2/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Cellulitis
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
2/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Infection
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Influenza
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Large intestine infection
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.75%
2/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
2/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Sepsis
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Skin candida
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Sweat gland infection
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.75%
4/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Headache
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Psychiatric disorders
Suicidal ideation
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Psychiatric disorders
Suicide attempt
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
C3 glomerulopathy
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
8/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.37%
1/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Vascular disorders
Thrombosis
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.19%
1/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
Other adverse events
| Measure |
AIN457 Q2W
n=181 participants at risk
Subjects who were randomized to AIN457 (secukinumab) 300mg Q2W dose regimen at the study entry. Adverse events were assessed up to Week 60
|
AIN457 Q4W
n=180 participants at risk
Subjects who were randomized to AIN457 (secukinumab) 300mg Q4W dose regimen at the study entry. Adverse events were assessed up to Week 60
|
Placebo
n=180 participants at risk
Subjects received matching placebo up to 16 weeks
|
Any AIN457 Q2W
n=266 participants at risk
Subjects who received at least 1 dose of secukinumab 300 mg Q2W dose (e.g., subjects who switched from placebo to secukinumab Q2W at Week 16). Adverse events were assessed up to Week 60
|
Any AIN457 Q4W
n=267 participants at risk
Subjects who received at least 1 dose of secukinumab 300 mg Q4W dose (e.g., subjects who switched from placebo to secukinumab Q4W at Week 16). Adverse events were assessed up to Week 60
|
Any AIN457
n=533 participants at risk
Subjects who received at least 1 dose of secukinumab
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
7/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
10/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
18/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.4%
13/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
6/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
11/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
8.9%
16/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.0%
9/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.5%
12/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.0%
24/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.8%
36/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.9%
7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.9%
13/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.6%
19/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Toothache
|
3.9%
7/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
16/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
5/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.9%
7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
15/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Asthenia
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
9/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Chest pain
|
0.00%
0/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.94%
5/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Fatigue
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.1%
11/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.9%
13/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.9%
21/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
General disorders
Pyrexia
|
7.2%
13/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.0%
16/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.5%
12/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
28/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.3%
7/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Bronchitis
|
2.8%
5/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.4%
13/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
COVID-19
|
2.8%
5/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.4%
13/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Cellulitis
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
6/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
12/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Conjunctivitis
|
2.8%
5/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
6/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
11/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Ear infection
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.3%
7/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Folliculitis
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
10/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Fungal skin infection
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.75%
4/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Gastroenteritis
|
4.4%
8/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
12/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Influenza
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.38%
1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
6/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.3%
7/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
17.7%
32/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
13.3%
24/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.2%
13/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
15.0%
40/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.9%
29/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.9%
69/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Pharyngitis
|
3.9%
7/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
15/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Sinusitis
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.75%
2/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
9/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Suspected COVID-19
|
2.8%
5/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.4%
13/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Tonsillitis
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
11/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
9/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.2%
13/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.5%
12/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
6.4%
17/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.4%
29/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
9/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
10/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
10/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.8%
20/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.3%
7/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
11/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
12/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Amylase increased
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
8/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Lipase increased
|
4.4%
8/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.9%
7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
17/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
SARS-CoV-2 test negative
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
15/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
SARS-CoV-2 test positive
|
1.1%
2/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
9/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
Weight increased
|
1.1%
2/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
8/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.3%
7/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
11/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.3%
14/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
23/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
7/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.5%
12/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.6%
19/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
10/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Dizziness
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
12/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Headache
|
18.2%
33/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
17.8%
32/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
7.8%
14/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
14.7%
39/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
17.2%
46/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
15.9%
85/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Nervous system disorders
Migraine
|
2.8%
5/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
8/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Psychiatric disorders
Depression
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
9/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.4%
8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.7%
10/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.2%
17/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
9/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.1%
11/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.6%
7/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
18/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.4%
8/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.4%
13/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
6/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
11/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
9/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.7%
3/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.00%
0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
6/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.7%
9/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.4%
8/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
9/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.4%
18/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
8.8%
16/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.4%
17/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
12.8%
23/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.5%
28/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
9.7%
26/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
10.1%
54/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
5.5%
10/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.9%
7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.1%
11/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.6%
19/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
11/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.3%
6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
5.6%
15/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
4.3%
23/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
11/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.1%
11/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.2%
4/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.8%
5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
6/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.3%
12/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Vascular disorders
Hypertension
|
3.3%
6/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
3.0%
8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.9%
5/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.4%
13/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Investigations
White blood cell count increased
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.75%
2/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.94%
5/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.55%
1/181 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.56%
1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
2.2%
4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
0.75%
2/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.5%
4/267 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
1.1%
6/533 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 60 weeks for AIN457 (up to 52 weeks for subjects moving to extension study) and 16 weeks for placebo.
AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
|
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