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Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

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ClinicalTrials.gov Identifier: NCT01544595
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Moderate to Severe Plaque-type Psoriasis
Interventions Drug: Secukinumab (AIN457)
Drug: Placebo
Enrollment 1147
Recruitment Details Among the 1146 patients who completed the screening phase, 995 “PASI 75 responder at week 52” patients were randomized in a double blind fashion to either active treatment or placebo & entered the randomized withdrawal period and 151 “partial responders at week 52" patients entered treatment period of the Extension.
Pre-assignment Details 1366 patients who completed the core studies (CAIN457A2302 or CAIN457A2303) and provided consent for participation in the extension study were screened, and 1146 (83.9%) completed the screening phase and entered the extension.
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period AIN457 150 mg - Partial Responders AIN457 300 mg - Partial Responders
Hide Arm/Group Description PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study
Period Title: Status at Week 68
Started 301 363 150 181 0 [1] 0 [1]
Completed [2] 262 346 87 130 0 [1] 0 [1]
Not Completed 39 17 63 51 0 0
Reason Not Completed
Adverse Event             3             2             1             0             0             0
Lack of Efficacy             1             0             0             0             0             0
Lost to Follow-up             1             1             0             0             0             0
Non-compliance with study treatment             1             0             0             1             0             0
Protocol Violation             2             0             1             1             0             0
Technical problems             1             0             0             1             0             0
Withdrawal by Subject             0             1             1             2             0             0
Moved to treatment period ≤ wk 68             30             13             60             46             0             0
[1]
These patients were not in the study arms at this time point.
[2]
Week 68
Period Title: Status at Week 156
Started 301 363 150 181 98 53
Completed [1] 184 285 10 15 60 38
Not Completed 117 78 140 166 38 15
Reason Not Completed
Withdrawal by Subject             9             10             4             9             20             6
Adverse Event             9             11             1             3             4             2
Lost to Follow-up             4             4             0             1             4             1
Non-compliance with study treatement             0             1             0             1             0             1
Physician Decision             0             3             1             0             0             0
Pregnancy             2             3             0             0             0             0
Protocol Violation             3             1             2             2             0             0
Technical problems             3             1             0             1             0             0
Moved to treatment period ≤ wk 156             86             44             131             145             0             0
Lack of Efficacy             1             0             1             4             10             5
[1]
Week 156
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period AIN457 150 mg - Partial Responders AIN457 300 mg - Partial Responders Total
Hide Arm/Group Description PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study Total of all reporting groups
Overall Number of Baseline Participants 301 363 150 181 98 53 1146
Hide Baseline Analysis Population Description
Randomized set was defined as all patients who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 363 participants 150 participants 181 participants 98 participants 53 participants 1146 participants
45.9  (12.93) 45.8  (12.92) 47.1  (13.34) 45.4  (13.09) 46.8  (12.78) 48.5  (11.98) 46.2  (12.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 363 participants 150 participants 181 participants 98 participants 53 participants 1146 participants
Female
83
  27.6%
102
  28.1%
45
  30.0%
62
  34.3%
28
  28.6%
10
  18.9%
330
  28.8%
Male
218
  72.4%
261
  71.9%
105
  70.0%
119
  65.7%
70
  71.4%
43
  81.1%
816
  71.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 301 participants 363 participants 150 participants 181 participants 98 participants 53 participants 1146 participants
Caucasian 213 276 115 136 73 42 855
Black 4 4 2 3 4 1 18
Asian 52 50 22 24 17 8 173
Native American 24 23 9 15 2 2 75
Pacific Islander 1 2 0 1 1 0 5
Unknown 0 1 1 1 0 0 3
Other 7 7 1 1 1 0 17
1.Primary Outcome
Title Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68
Hide Description

The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52).

Loss of PASI 75 response was analyzed by means of a survival analysis defining “loss of PASI 75 response” as “failure”. The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t.

PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.

Time Frame At week 68 (16 weeks after week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): patients from randomized set with at least 1 post baseline efficacy assessment.
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cummulative rate
49.8
(25.8 to 79.7)
25.4
(9.8 to 56.5)
74.3
(56.9 to 88.8)
64.7
(52.0 to 77.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457 150 mg –Randomized Withdrawal Period, AIN457 150 mg Placebo - Randomized Withdrawal Period
Comments

The following hypotheses were tested for 52 weeks≤ t ≤68 weeks

  • H1: p1(t) – p0,1(t) = 0 versus HA1: p1(t)– p0,1(t) ≥ 0,
  • H2: p2(t) – p0,2(t) = 0 versus HA2: p2(t) – p0,2(t) ≥ 0,
Type of Statistical Test Superiority
Comments

H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68

• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68

Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.22 to 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AIN457 300 mg –Randomized Withdrawal Period, AIN457 300 mg Placebo - Randomized Withdrawal Period
Comments

The following hypotheses were tested for 52 weeks≤ t ≤68 weeks

  • H1: p1(t) – p0,1(t) = 0 versus HA1: p1(t)– p0,1(t) ≥ 0,
  • H2: p2(t) – p0,2(t) = 0 versus HA2: p2(t) – p0,2(t) ≥ 0,
Type of Statistical Test Superiority
Comments

H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68

• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68

Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.14 to 0.29
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period
Hide Description

Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab.

PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement [reduction] in PASI score compared to baseline of the core study).

PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders.

PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders.

PASI 100 response/remission: complete clearing of psoriasis (PASI=0)

Time Frame Week 52, 104, and 156
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Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Measure Type: Number
Unit of Measure: Number of participants
Wk 52 - IGA 0/1 Number Analyzed 297 participants 363 participants 150 participants 180 participants
208 309 112 157
Wk 52 - PASI 50 Number Analyzed 297 participants 363 participants 150 participants 180 participants
297 363 149 180
Wk 52 - PASI 75 Number Analyzed 297 participants 363 participants 150 participants 180 participants
296 361 149 179
Wk 52 - PASI 90 Number Analyzed 297 participants 363 participants 150 participants 180 participants
190 303 105 156
Wk 52 - PASI 100 Number Analyzed 297 participants 363 participants 150 participants 180 participants
93 191 54 96
Wk 104 - IGA 0/1 Number Analyzed 260 participants 338 participants 20 participants 34 participants
128 236 8 13
Wk 104 - PASI 50 Number Analyzed 260 participants 338 participants 20 participants 34 participants
254 329 19 28
Wk 104 - PASI 75 Number Analyzed 260 participants 338 participants 20 participants 34 participants
209 299 15 21
Wk 104 - PASI 90 Number Analyzed 260 participants 338 participants 20 participants 34 participants
125 240 6 13
Wk 104 - PASI 100 Number Analyzed 260 participants 338 participants 20 participants 34 participants
65 151 4 6
Wk 156 - IGA 0/1 Number Analyzed 239 participants 324 participants 10 participants 15 participants
90 202 4 7
Wk 156 - PASI 50 Number Analyzed 239 participants 324 participants 10 participants 15 participants
230 322 10 15
Wk 156 - PASI 75 Number Analyzed 239 participants 324 participants 10 participants 15 participants
183 287 6 13
Wk 156 - PASI 90 (n=239, 324, 10,15) Number Analyzed 239 participants 324 participants 10 participants 15 participants
101 207 4 7
Wk 156 - PASI 100 Number Analyzed 239 participants 324 participants 10 participants 15 participants
47 117 2 5
3.Secondary Outcome
Title Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period
Hide Description Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.
Time Frame Week 52, Week 104, Week 156, week 208, week 260
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Measure Type: Number
Unit of Measure: Number of participants
Wk 52 - PASI 50 Number Analyzed 164 participants 416 participants
164 416
Wk 52 - PASI 75 Number Analyzed 164 participants 416 participants
121 361
Wk 52 - PASI 90 Number Analyzed 164 participants 416 participants
85 303
Wk 52 - PASI 100 Number Analyzed 164 participants 416 participants
54 191
Wk 104 - PASI 50 Number Analyzed 104 participants 377 participants
99 359
Wk 104 - PASI 75 Number Analyzed 104 participants 377 participants
76 314
Wk 104 - PASI 90 Number Analyzed 104 participants 377 participants
62 243
Wk 104 - PASI 100 Number Analyzed 104 participants 377 participants
46 153
Wk 156 - PASI 50 Number Analyzed 69 participants 361 participants
67 351
Wk 156 - PASI Number Analyzed 69 participants 361 participants
63 297
Wk 156 - PASI 90 Number Analyzed 69 participants 361 participants
52 211
Wk 156 - PASI 100 Number Analyzed 69 participants 361 participants
37 118
Wk 208 - PASI 50 Number Analyzed 58 participants 323 participants
58 316
Wk 208 - PASI 75 Number Analyzed 58 participants 323 participants
55 269
Wk 208 - PASI 90 Number Analyzed 58 participants 323 participants
51 194
Wk 208 - PASI 100 Number Analyzed 58 participants 323 participants
33 104
Wk 260 - PASI 50 Number Analyzed 51 participants 285 participants
51 279
Wk 260 - PASI 75 Number Analyzed 51 participants 285 participants
49 231
Wk 260 - PASI 90 Number Analyzed 51 participants 285 participants
37 179
Wk 260 - PASI 100 Number Analyzed 51 participants 285 participants
26 100
4.Secondary Outcome
Title Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period
Hide Description

The improvement (decrease from baseline) in PASI total scores observed at Week 52.

Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.

Time Frame Week 52, 104, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Mean (Standard Deviation)
Unit of Measure: Percent change in PASI score
Week 52 (baseline) Number Analyzed 297 participants 363 participants 150 participants 180 participants
-92.31  (7.878) -95.98  (6.638) -92.88  (8.435) -96.16  (6.030)
Week 104 Number Analyzed 260 participants 338 participants 20 participants 34 participants
-85.88  (14.631) -91.51  (13.221) -82.67  (15.568) -78.04  (20.986)
Week 156 Number Analyzed 239 participants 324 participants 10 participants 15 participants
-83.32  (17.341) -90.50  (11.660) -79.77  (15.172) -86.35  (15.602)
5.Secondary Outcome
Title Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period
Hide Description Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.
Time Frame Week 52, Week 104, Week 156, week 208, week 260
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Mean (Standard Deviation)
Unit of Measure: Percent change in PASI score
Wk 52 Number Analyzed 164 participants 416 participants
-85.93  (14.815) -91.82  (11.889)
Wk 104 Number Analyzed 104 participants 377 participants
-85.97  (18.811) -88.86  (16.151)
Wk 156 Number Analyzed 69 participants 361 participants
-93.03  (12.338) -87.78  (15.114)
Wk 208 Number Analyzed 58 participants 323 participants
-95.71  (7.868) -88.25  (14.496)
Wk 260 Number Analyzed 51 participants 285 participants
-93.65  (9.959) -88.08  (14.983)
6.Secondary Outcome
Title Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period
Hide Description

Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions).

Patients in the placebo groups were not evaluable after re-treatment with Secukinumab

Time Frame Week 52 (baseline), 104, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Measure Type: Number
Unit of Measure: Number of participants
Wk 52 - clear Number Analyzed 297 participants 363 participants 150 participants 180 participants
95 188 56 94
Wk 52 - almost clear Number Analyzed 297 participants 363 participants 150 participants 180 participants
113 121 56 63
Wk 52 - mild Number Analyzed 297 participants 363 participants 150 participants 180 participants
75 44 33 22
Wk 52 - moderate Number Analyzed 297 participants 363 participants 150 participants 180 participants
14 9 4 1
Wk 52 - severe Number Analyzed 297 participants 363 participants 150 participants 180 participants
0 1 1 0
Wk 104 - clear Number Analyzed 260 participants 338 participants 20 participants 34 participants
66 152 3 4
Wk 104 - almost clear Number Analyzed 260 participants 338 participants 20 participants 34 participants
62 84 5 9
Wk 104 - mild Number Analyzed 260 participants 338 participants 20 participants 34 participants
78 64 9 9
Wk 104 - moderate Number Analyzed 260 participants 338 participants 20 participants 34 participants
47 33 3 10
Wk 104 - severe Number Analyzed 260 participants 338 participants 20 participants 34 participants
7 5 0 2
Wk 156 - clear Number Analyzed 239 participants 324 participants 10 participants 15 participants
48 115 2 4
Wk 156 - almost clear Number Analyzed 239 participants 324 participants 10 participants 15 participants
42 87 2 3
Wk 156 - mild Number Analyzed 239 participants 324 participants 10 participants 15 participants
88 78 2 5
Wk 156 - moderate Number Analyzed 239 participants 324 participants 10 participants 15 participants
59 43 4 2
Wk 156 - severe Number Analyzed 239 participants 324 participants 10 participants 15 participants
2 1 0 1
7.Secondary Outcome
Title Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period
Hide Description Investigator’s Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)
Time Frame Week 52, Week 104, Week 156, week 208, week 260
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Measure Type: Number
Unit of Measure: Number of participants
Wk 52 - clear Number Analyzed 164 participants 416 participants
56 188
Wk 52 - almost clear Number Analyzed 164 participants 416 participants
38 123
Wk 52 - mild Number Analyzed 164 participants 416 participants
44 71
Wk 52 - moderate Number Analyzed 164 participants 416 participants
26 32
Wk 52 - severe Number Analyzed 164 participants 416 participants
0 2
Wk 104 - clear Number Analyzed 104 participants 377 participants
47 154
Wk 104 - almost clear Number Analyzed 104 participants 377 participants
16 85
Wk 104 - mild Number Analyzed 104 participants 377 participants
17 80
Wk 104 - moderate Number Analyzed 104 participants 377 participants
19 51
Wk 104 - severe Number Analyzed 104 participants 377 participants
5 7
Wk 156 - clear Number Analyzed 69 participants 361 participants
37 116
Wk 156 - almost clear Number Analyzed 69 participants 361 participants
13 90
Wk 156 - mild Number Analyzed 69 participants 361 participants
11 91
Wk 156 - moderate Number Analyzed 69 participants 361 participants
8 61
Wk 156 - severe Number Analyzed 69 participants 361 participants
0 3
Wk 208 - clear Number Analyzed 58 participants 323 participants
33 102
Wk 208 - almost clear Number Analyzed 58 participants 323 participants
14 81
Wk 208 - mild Number Analyzed 58 participants 323 participants
7 88
Wk 208 - moderate Number Analyzed 58 participants 323 participants
3 47
Wk 208 - severe Number Analyzed 58 participants 323 participants
1 5
Wk 260 - clear Number Analyzed 51 participants 285 participants
27 97
Wk 260 - almost clear Number Analyzed 51 participants 285 participants
12 65
Wk 260 - mild Number Analyzed 51 participants 285 participants
8 66
Wk 260 - moderate Number Analyzed 51 participants 285 participants
4 53
Wk 260 - severe Number Analyzed 51 participants 285 participants
0 4
8.Secondary Outcome
Title Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period
Hide Description Investigator’s Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.
Time Frame Week 52, Week 104, Week 156, week 208, week 260
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Measure Type: Number
Unit of Measure: Number of participants
Wk 52 Number Analyzed 164 participants 416 participants
94 311
Wk 104 Number Analyzed 104 participants 377 participants
63 239
Wk 156 Number Analyzed 69 participants 361 participants
50 206
Wk 208 Number Analyzed 58 participants 323 participants
47 183
Wk 260 Number Analyzed 51 participants 285 participants
39 162
9.Secondary Outcome
Title Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period
Hide Description

Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52.

time = 0 refers to Week 52

Time Frame Week 68
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
38.1
(29.8 to 47.7)
33.4
(25.7 to 42.6)
82.1
(71.2 to 90.8)
65.5
(53.8 to 77.0)
10.Secondary Outcome
Title Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse
Hide Description PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52
Time Frame up to week 260
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed
Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed
Overall Number of Participants Analyzed 131 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
0 to <=4 wks Number Analyzed 131 participants 145 participants
38.5
(30.7 to 47.4)
51.0
(43.2 to 59.5)
>12 to <=16 wks (n=21,13) Number Analyzed 21 participants 13 participants
91.2
(85.5 to 95.3)
95.1
(90.7 to 97.8)
>80 to <=84 wks (n=2,1) Number Analyzed 2 participants 1 participants
96.8
(92.6 to 98.9)
98.8
(94.8 to 99.9)
11.Secondary Outcome
Title Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse
Hide Description

IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse.

time = 0 refers to Week 52

Time Frame up to week 260
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo - AIN457 150 mg Placebo - AIN457 300 mg
Hide Arm/Group Description:
Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed
Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed
Overall Number of Participants Analyzed 131 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
0 to <=4 wks (n=96,123) Number Analyzed 96 participants 123 participants
12.5
(7.3 to 21.0)
28.1
(21.0 to 37.0)
>12 to <=16 wks (n=40,32) Number Analyzed 40 participants 32 participants
75.0
(66.0 to 83.1)
83.5
(76.3 to 89.4)
>84 to <=88 wks (n=7,4) Number Analyzed 7 participants 4 participants
87.9
(80.0 to 93.8)
90.8
(84.5 to 95.4)
12.Secondary Outcome
Title Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period
Hide Description Time 0 = week 52
Time Frame up to week 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants with relapses
0 to <=4 wks (n=286,353,150,180) Number Analyzed 286 participants 353 participants 150 participants 180 participants
0.3
(0.0 to 2.4)
0.3
(0.0 to 1.9)
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.0)
>12 to <=16 wks (n=297,363,124,160) Number Analyzed 297 participants 363 participants 124 participants 160 participants
3.1
(1.6 to 5.9)
2.2
(1.1 to 4.4)
19.8
(13.9 to 27.7)
12.1
(8.0 to 18.1)
>92 to <=96 wks (n=188,292,11,15) Number Analyzed 188 participants 292 participants 11 participants 15 participants
21.5
(16.9 to 27.0)
9.4
(6.8 to 13.1)
88.1
(80.9 to 93.5)
86.1
(79.6 to 91.4)
>104 to <=108 wks (n=156,297,8,9) Number Analyzed 156 participants 297 participants 8 participants 9 participants
21.9
(17.3 to 27.5)
9.4
(6.8 to 13.1)
88.1
(80.9 to 93.5)
86.1
(79.6 to 91.4)
13.Secondary Outcome
Title Percent of Participants With Relapse After Last Injection
Hide Description

Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by >50%.

Time 0 = week 52

Time Frame up to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants with relapse
0 to <=4 wks (n=158,415) Number Analyzed 158 participants 415 participants
7.2
(4.0 to 12.6)
2.0
(1.0 to 3.9)
>12 to <=16 wks (n=66,208) Number Analyzed 66 participants 208 participants
34.0
(22.6 to 48.9)
28.4
(21.8 to 36.6)
14.Secondary Outcome
Title Percent of Participants With Rebound After Last Injection
Hide Description Rebound: PASI increases to > 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of > 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.
Time Frame up to week 68
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Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants with rebound
Rebound (<8 wks after last inj.; n=108,320) Number Analyzed 108 participants 320 participants
8.3
(4.1 to 15.6)
6.6
(4.2 to 10.0)
RLE (< 12 wks after last inj., n=110,326) Number Analyzed 110 participants 326 participants
11.8
(6.7 to 19.7)
9.5
(6.7 to 13.4)
15.Secondary Outcome
Title Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)
Hide Description Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.
Time Frame Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 295 359 150 180
Measure Type: Number
Unit of Measure: Number of participants
Week 52 (baseline) Number Analyzed 295 participants 359 participants 150 participants 180 participants
196 281 109 142
Week 64 Number Analyzed 290 participants 357 participants 126 participants 162 participants
170 265 59 90
Week 76 Number Analyzed 284 participants 352 participants 71 participants 104 participants
163 256 26 38
Week 88 Number Analyzed 281 participants 346 participants 34 participants 62 participants
157 247 18 24
Week 104 Number Analyzed 262 participants 337 participants 21 participants 35 participants
146 237 10 14
Week 116 Number Analyzed 252 participants 326 participants 16 participants 24 participants
141 230 6 9
Week 128 Number Analyzed 251 participants 326 participants 14 participants 19 participants
139 222 4 10
Week 140 Number Analyzed 241 participants 327 participants 12 participants 18 participants
126 229 4 7
Week 156 Number Analyzed 240 participants 324 participants 11 participants 15 participants
119 215 5 8
16.Secondary Outcome
Title Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period
Hide Description Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.
Time Frame Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Measure Type: Number
Unit of Measure: Number of participants
Week 52 (baseline) Number Analyzed 162 participants 412 participants
95 299
Week 104 Number Analyzed 113 participants 377 participants
66 254
week 156 Number Analyzed 69 participants 362 participants
47 225
Week 208 Number Analyzed 53 participants 328 participants
41 207
week 260 Number Analyzed 52 participants 286 participants
42 174
17.Secondary Outcome
Title EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period
Hide Description EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time Frame Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 297 363 150 180
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 64 Number Analyzed 283 participants 348 participants 125 participants 162 participants
0.03  (21.603) 2.09  (28.358) -9.58  (20.339) -5.57  (27.889)
Week 76 Number Analyzed 256 participants 337 participants 72 participants 103 participants
0.79  (25.605) 2.76  (29.715) -13.73  (23.295) -9.27  (35.302)
Week 88 Number Analyzed 241 participants 323 participants 34 participants 60 participants
0.07  (21.421) 2.15  (29.702) -10.24  (26.026) -14.67  (27.975)
Week 104 Number Analyzed 214 participants 310 participants 21 participants 36 participants
2.37  (24.075) 1.57  (23.941) -2.81  (27.303) -9.65  (17.794)
Week 116 Number Analyzed 205 participants 295 participants 16 participants 23 participants
2.12  (31.724) 2.06  (24.814) -4.82  (20.921) -3.44  (11.846)
Week 128 Number Analyzed 201 participants 292 participants 14 participants 19 participants
2.06  (33.078) 3.17  (29.615) -5.59  (21.756) -5.97  (13.207)
Week 140 Number Analyzed 189 participants 288 participants 12 participants 18 participants
1.20  (25.801) 0.71  (18.151) -5.90  (27.335) -8.86  (18.344)
Week 156 Number Analyzed 180 participants 284 participants 11 participants 15 participants
2.53  (34.259) 2.23  (22.581) 3.68  (26.836) -7.60  (20.683)
18.Secondary Outcome
Title EQ-5D Health State Assessment (Observed Value) - Entire Study Period
Hide Description EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient’s health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent’s self-rated health on a vertical scale where the endpoints are labeled ‘Best imaginable health state’ and ‘Worst imaginable health state’. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time Frame week 64, 76, 88, 104, 116, 128, 140, and 156
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AIN457 150 mg Only AIN457 300 mg Only
Hide Arm/Group Description:
patients staying strictly on AIN457 150mg from Week 52
Patients staying strictly on AIN457 300mg from Week 52
Overall Number of Participants Analyzed 164 416
Mean (Standard Deviation)
Unit of Measure: Percent change
Week 64 Number Analyzed 155 participants 404 participants
-1.33  (22.506) 1.44  (26.815)
Week 76 Number Analyzed 144 participants 398 participants
-1.99  (22.339) 2.10  (28.493)
Week 88 Number Analyzed 130 participants 387 participants
-0.66  (24.558) 1.45  (28.269)
Week 104 Number Analyzed 112 participants 376 participants
-4.15  (27.823) 0.65  (23.454)
Week 116 Number Analyzed 93 participants 364 participants
-1.19  (21.022) 1.21  (23.681)
Week 128 Number Analyzed 84 participants 365 participants
-2.85  (23.584) 1.93  (27.840)
Week 140 Number Analyzed 75 participants 367 participants
0.09  (20.814) -0.44  (18.504)
Week 156 Number Analyzed 67 participants 365 participants
2.13  (32.326) 1.19  (21.548)
19.Secondary Outcome
Title Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period
Hide Description

CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.

IR=incidence rate per 100 subject years

Time Frame Week 52-156
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 301 363 150 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: IR
Leukocytes (< LLN - 3.0 x 10E9/L)
7.0
(4.7 to 10.1)
4.9
(3.3 to 7.0)
7.2
(2.6 to 15.6)
8.6
(4.1 to 15.8)
Leukocytes (< 3.0 - 2.0 x 10E9/L)
1.4
(0.5 to 3.0)
0.8
(0.3 to 1.9)
0.0
(0.0 to 4.3)
0.0
(0.0 to 3.1)
Leukocytes (< 2.0 - 1.0 x 10E9/L)
0.2
(0.0 to 1.3)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.3)
0.0
(0.0 to 3.1)
Leukocytes (< 1.0 x 10E9/L)
0.0
(0.0 to 0.8)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.3)
0.0
(0.0 to 3.1)
Lymphocytes (<LLN-0.8x10e9 /L)
6.4
(4.2 to 9.4)
6.1
(4.3 to 8.5)
4.9
(1.3 to 12.6)
6.0
(2.4 to 12.4)
Lymphocytes (<0.8-0.5x10e9 /L)
3.0
(1.6 to 5.2)
1.8
(0.9 to 3.2)
6.3
(2.1 to 14.7)
3.4
(0.9 to 8.6)
Lymphocytes (<0.5-0.2 x 10e9 /L)
0.2
(0.0 to 1.3)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.5)
0.0
(0.0 to 3.1)
Lymphocytes (<0.2x10e9 /L)
0.0
(0.0 to 0.8)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.5)
0.0
(0.0 to 3.1)
Neutrophils (<LLN-1.5x10e9 /L)
5.9
(3.8 to 8.7)
5.6
(3.8 to 7.8)
8.7
(3.5 to 18.0)
11.3
(6.0 to 19.3)
Neutrophils (<1.5-1.0x10e9 /L)
1.4
(0.5 to 3.0)
1.8
(0.9 to 3.2)
2.4
(0.3 to 8.8)
0.0
(0.0 to 3.1)
Neutrophils (<1.0 - 0.5x10e9 /L)
0.9
(0.3 to 2.4)
0.5
(0.1 to 1.4)
0.0
(0.0 to 4.5)
0.0
(0.0 to 3.1)
Neutrophils (<0.5x10e9 /L)
0.0
(0.0 to 0.8)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.5)
0.0
(0.0 to 3.1)
Platelets (LLN-75 x10e9 /L)
3.3
(1.8 to 5.5)
3.1
(1.9 to 4.9)
2.4
(0.3 to 8.6)
5.4
(2.0 to 11.9)
Platelets (<75-50 x 10e9 /L)
0.2
(0.0 to 1.3)
0.2
(0.0 to 0.9)
0.0
(0.0 to 4.4)
0.0
(0.0 to 3.2)
Platelets (<50-25 x 10e9 /L)
0.0
(0.0 to 0.8)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.4)
0.0
(0.0 to 3.2)
Platelets (<25x10e9 /L)
0.0
(0.0 to 0.8)
0.2
(0.0 to 0.9)
0.0
(0.0 to 4.4)
0.0
(0.0 to 3.2)
20.Secondary Outcome
Title Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period
Hide Description CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.
Time Frame approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were be analyzed according to treatment received.
Arm/Group Title Any AIN457 150 mg Any AIN457 300 mg Any AIN457
Hide Arm/Group Description:
Safety data from patients while on AIN457 150 mg
Safety data from patients while on AIN457 300 mg
safety data from patients while on any dose of AIN457
Overall Number of Participants Analyzed 545 890 1113
Measure Type: Number
Unit of Measure: Participants
Leukocytes (<LLN-3.0x10e9 /L) Number Analyzed 545 participants 832 participants 1037 participants
55 59 114
Leukocytes (<3.0-2.0 x 10e9 /L) Number Analyzed 545 participants 866 participants 1080 participants
10 7 17
Leukocytes (<2.0-1.0x10e9 /L) Number Analyzed 545 participants 870 participants 1085 participants
1 0 1
Leukocytes (<1.0x10e9 /L) Number Analyzed 545 participants 870 participants 1085 participants
0 0 0
Lymphocytes (<LLN-0.8x10e9 /L) Number Analyzed 545 participants 840 participants 1041 participants
47 61 108
Lymphocytes (<0.8-0.5x10e9 /L) Number Analyzed 545 participants 861 participants 1071 participants
18 28 46
Lymphocytes (<0.5-0.2 x 10e9 /L, n=545,864,1075) Number Analyzed 545 participants 864 participants 1075 participants
1 1 2
Lymphocytes (<0.2x10e9 /L, n=545,864,1075) Number Analyzed 545 participants 864 participants 1075 participants
0 0 0
Neutrophils (<LLN-1.5x10e9 /L) Number Analyzed 545 participants 831 participants 1037 participants
54 69 123
Neutrophils (<1.5-1.0x10e9 /L) Number Analyzed 545 participants 861 participants 1071 participants
12 20 32
Neutrophils (<1.0 - 0.5x10e9 /L,) Number Analyzed 545 participants 863 participants 1074 participants
7 4 11
Neutrophils (<0.5x10e9 /L) Number Analyzed 545 participants 864 participants 1075 participants
0 0 0
Platelets (LLN-75x10e9 /L) Number Analyzed 545 participants 836 participants 1042 participants
24 39 63
Platelets (<75-50x10e9 /L,) Number Analyzed 545 participants 862 participants 1074 participants
2 2 4
Platelets (<50-25 x 10e9 /L) Number Analyzed 545 participants 862 participants 1074 participants
0 0 0
Platelets (<25x10e9 /L) Number Analyzed 545 participants 862 participants 1074 participants
0 1 1
21.Secondary Outcome
Title Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period
Hide Description

QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.

IR=incidence rate per 100 subject years.

Time Frame Week 52 - 156
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title AIN457 150 mg –Randomized Withdrawal Period AIN457 300 mg –Randomized Withdrawal Period AIN457 150 mg Placebo - Randomized Withdrawal Period AIN457 300 mg Placebo - Randomized Withdrawal Period
Hide Arm/Group Description:
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
Overall Number of Participants Analyzed 301 363 150 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: IR
QTcB>450 msec
10.5
(7.5 to 14.3)
9.4
(7.0 to 12.4)
11.3
(4.9 to 22.3)
14.1
(7.5 to 24.0)
QTcB>480 msec
0.7
(0.1 to 2.0)
1.1
(0.5 to 2.3)
0.0
(0.0 to 4.7)
0.0
(0.0 to 3.3)
QTcB>500 msec
0.2
(0.0 to 1.3)
0.2
(0.0 to 0.9)
0.0
(0.0 to 4.7)
0.0
(0.0 to 3.3)
QTcB change from baseline>30 ms
15.6
(11.9 to 20.1)
14.3
(11.4 to 17.9)
21.6
(12.3 to 35.0)
15.7
(9.0 to 25.5)
QTcB change from baseline>60 ms
0.7
(0.1 to 2.0)
0.8
(0.3 to 1.9)
0.0
(0.0 to 4.7)
0.0
(0.0 to 3.3)
QTcF>450 msec
3.6
(2.0 to 6.0)
3.0
(1.8 to 4.7)
2.6
(0.3 to 9.5)
4.7
(1.5 to 10.9)
QTcF>480 msec
0.5
(0.1 to 1.7)
0.2
(0.0 to 0.9)
0.0
(0.0 to 4.7)
0.9
(0.0 to 5.0)
QTcF>500 msec
0.0
(0.0 to 0.8)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.7)
0.0
(0.0 to 3.3)
QTcF change from baseline>30 ms
6.9
(4.6 to 9.9)
6.8
(4.8 to 9.2)
7.9
(2.9 to 17.2)
9.5
(4.6 to 17.5)
QTcF change from baseline>60 ms
0.2
(0.0 to 1.3)
0.2
(0.0 to 0.9)
0.0
(0.0 to 4.7)
0.0
(0.0 to 3.3)
PR>250 msec
0.2
(0.0 to 1.3)
0.0
(0.0 to 0.6)
0.0
(0.0 to 4.9)
0.0
(0.0 to 3.3)
22.Secondary Outcome
Title Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period
Hide Description QTcB: QT interval corrected using Bazett’s formula QTcF: QT interval corrected using Fridericia’s formula A patient with multiple variable measurements is counted only once under the worst condition.
Time Frame Approximately 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set
Arm/Group Title Any AIN457 150 mg Any AIN457 300 mg Any AIN457
Hide Arm/Group Description:
Safety data from patients while on AIN457 150 mg
Safety data from patients while on AIN457 300 mg
safety data from patients while on any dose of AIN457
Overall Number of Participants Analyzed 545 890 1113
Measure Type: Number
Unit of Measure: Participants
QTcB>500 msec Number Analyzed 545 participants 851 participants 1060 participants
1 2 3
QTcB>480 msec Number Analyzed 545 participants 848 participants 1056 participants
8 23 30
QTcB>450 msec Number Analyzed 545 participants 804 participants 1004 participants
86 159 218
QTcB changes from baseline>30 ms Number Analyzed 545 participants 851 participants 1060 participants
124 223 316
QTcB changes from baseline>60 ms Number Analyzed 545 participants 851 participants 1060 participants
7 19 25
QTcF>500 msec Number Analyzed 545 participants 851 participants 1060 participants
0 1 1
QTcF>480 msec Number Analyzed 545 participants 851 participants 1059 participants
3 6 8
QTcF>450 msec (n=545,838,1043) Number Analyzed 545 participants 838 participants 1043 participants
35 67 93
QTcF changes from baseline>30 ms Number Analyzed 545 participants 851 participants 1060 participants
69 127 184
QTcF changes from baseline>60 ms Number Analyzed 545 participants 851 participants 1060 participants
1 3 4
PR>250 msec Number Analyzed 545 participants 845 participants 1051 participants
4 5 8
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
Adverse Event Reporting Description Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
 
Arm/Group Title Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose AIN457 150 mg - Placebo AIN457 300 mg - Placebo
Hide Arm/Group Description safety data from patients while on AIN457 150 mg safety data from patients while on AIN457 300 mg safety data from patients while on any dose of AIN457 safety data from patients of corresponding randomized withdrawal group while on placebo safety data from patients of corresponding randomized withdrawal group while on placebo
All-Cause Mortality
Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose AIN457 150 mg - Placebo AIN457 300 mg - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/545 (0.00%)   2/890 (0.22%)   2/1113 (0.18%)   0/150 (0.00%)   0/181 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose AIN457 150 mg - Placebo AIN457 300 mg - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/545 (11.19%)   143/890 (16.07%)   198/1113 (17.79%)   4/150 (2.67%)   13/181 (7.18%) 
Blood and lymphatic system disorders           
Anaemia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Immune thrombocytopenic purpura  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cardiac disorders           
Acute coronary syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Acute myocardial infarction  1  0/545 (0.00%)  4/890 (0.45%)  4/1113 (0.36%)  0/150 (0.00%)  0/181 (0.00%) 
Angina pectoris  1  0/545 (0.00%)  4/890 (0.45%)  4/1113 (0.36%)  0/150 (0.00%)  0/181 (0.00%) 
Angina unstable  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Atrial fibrillation  1  1/545 (0.18%)  9/890 (1.01%)  10/1113 (0.90%)  0/150 (0.00%)  0/181 (0.00%) 
Atrioventricular block complete  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Coronary artery disease  1  1/545 (0.18%)  3/890 (0.34%)  4/1113 (0.36%)  0/150 (0.00%)  0/181 (0.00%) 
Coronary artery stenosis  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  1/150 (0.67%)  0/181 (0.00%) 
Myocardial infarction  1  1/545 (0.18%)  2/890 (0.22%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Myocardial ischaemia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Stress cardiomyopathy  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Tachycardia paroxysmal  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ventricular fibrillation  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Congenital, familial and genetic disorders           
Malformation venous  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Endocrine disorders           
Hyperandrogenism  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Thyroid mass  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Eye disorders           
Cataract  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Retinal detachment  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  1/181 (0.55%) 
Diverticulum  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Diverticulum intestinal  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  1/181 (0.55%) 
Duodenal ulcer haemorrhage  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Dyspepsia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Enterocolitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Functional gastrointestinal disorder  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Gastric ulcer  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Gastrooesophageal reflux disease  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Haemorrhoids  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ileus paralytic  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Incarcerated inguinal hernia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Inguinal hernia  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Intestinal perforation  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Intestinal polyp  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Intestinal pseudo-obstruction  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Irritable bowel syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Large intestinal stenosis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Large intestine perforation  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Large intestine polyp  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Pancreatitis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pancreatitis acute  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Umbilical hernia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Umbilical hernia, obstructive  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
General disorders           
Asthenia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Chest discomfort  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Face oedema  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Impaired healing  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Medical device site granuloma  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Multiple organ dysfunction syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Non-cardiac chest pain  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Hepatobiliary disorders           
Autoimmune hepatitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Bile duct stone  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cholangitis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cholangitis acute  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cholecystitis  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Cholecystitis acute  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Cholelithiasis  1  2/545 (0.37%)  1/890 (0.11%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Hepatic steatosis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Hepatitis acute  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Hepatitis toxic  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Jaundice  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Immune system disorders           
Drug hypersensitivity  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Sarcoidosis  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Infections and infestations           
Abscess limb  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Abscess neck  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Acute sinusitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Appendicitis  1  2/545 (0.37%)  2/890 (0.22%)  4/1113 (0.36%)  0/150 (0.00%)  2/181 (1.10%) 
Appendicitis perforated  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  1/150 (0.67%)  0/181 (0.00%) 
Bronchitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cellulitis  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  1/150 (0.67%)  1/181 (0.55%) 
Cholecystitis infective  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Chronic sinusitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Chronic tonsillitis  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Device related infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Diverticulitis  1  3/545 (0.55%)  1/890 (0.11%)  4/1113 (0.36%)  0/150 (0.00%)  1/181 (0.55%) 
Enterococcal bacteraemia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Epididymitis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Erysipelas  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  1/181 (0.55%) 
Escherichia infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Gallbladder empyema  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Gastroenteritis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Graft infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Hepatitis A  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Implant site infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Localised infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Oesophageal candidiasis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Oophoritis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Osteomyelitis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Otitis media  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Periorbital cellulitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Peritonitis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Peritonsillar abscess  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pharyngeal abscess  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pharyngitis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pneumonia  1  1/545 (0.18%)  4/890 (0.45%)  5/1113 (0.45%)  0/150 (0.00%)  0/181 (0.00%) 
Pneumonia influenzal  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Post procedural infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Postoperative wound infection  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pyelonephritis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Rhinitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Sepsis  1  0/545 (0.00%)  4/890 (0.45%)  4/1113 (0.36%)  0/150 (0.00%)  0/181 (0.00%) 
Septic shock  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Sinusitis  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Streptococcal infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Tick-borne viral encephalitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Tonsillitis  1  2/545 (0.37%)  2/890 (0.22%)  4/1113 (0.36%)  0/150 (0.00%)  0/181 (0.00%) 
Tooth infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Urinary tract infection  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Viral pericarditis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Wound infection  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Injury, poisoning and procedural complications           
Accident  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ankle fracture  1  2/545 (0.37%)  1/890 (0.11%)  3/1113 (0.27%)  0/150 (0.00%)  1/181 (0.55%) 
Cardiac procedure complication  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Clavicle fracture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Concussion  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Contusion  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Facial bones fracture  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Fibula fracture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  1/150 (0.67%)  0/181 (0.00%) 
Foot fracture  1  0/545 (0.00%)  3/890 (0.34%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Head injury  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Humerus fracture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Incisional hernia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Jaw fracture  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Kidney rupture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ligament injury  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Ligament rupture  1  1/545 (0.18%)  2/890 (0.22%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Limb injury  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Lower limb fracture  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Meniscus injury  1  0/545 (0.00%)  3/890 (0.34%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Multiple fractures  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Muscle rupture  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Overdose  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Post-traumatic neck syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Procedural hypertension  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Radius fracture  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  1/181 (0.55%) 
Soft tissue injury  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Spinal fracture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Tendon injury  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Tendon rupture  1  0/545 (0.00%)  3/890 (0.34%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Tibia fracture  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  1/150 (0.67%)  0/181 (0.00%) 
Ulna fracture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Wrist fracture  1  1/545 (0.18%)  2/890 (0.22%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Metabolism and nutrition disorders           
Diabetes mellitus  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Arthritis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Dupuytren's contracture  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Haemarthrosis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Intervertebral disc degeneration  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Intervertebral disc protrusion  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  1/181 (0.55%) 
Joint instability  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Lumbar spinal stenosis  1  1/545 (0.18%)  2/890 (0.22%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Osteitis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Osteoarthritis  1  1/545 (0.18%)  4/890 (0.45%)  5/1113 (0.45%)  0/150 (0.00%)  0/181 (0.00%) 
Psoriatic arthropathy  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  1/181 (0.55%) 
Rotator cuff syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Spinal column stenosis  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Spinal pain  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Acute leukaemia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Adenocarcinoma of colon  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Anal squamous cell carcinoma  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Breast cancer  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Gallbladder cancer  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Gastric cancer  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Haemangioma  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Hepatic cancer metastatic  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Intraductal proliferative breast lesion  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Invasive breast carcinoma  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Malignant melanoma in situ  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Meningioma benign  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Metastases to lung  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Papillary thyroid cancer  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Prostate cancer  1  2/545 (0.37%)  1/890 (0.11%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Small cell lung cancer  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Uterine leiomyoma  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Nervous system disorders           
Cerebral infarction  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cerebral ischaemia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cerebrovascular accident  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Complex regional pain syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Cranial nerve paralysis  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Diabetic neuropathy  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Dizziness  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Drooling  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Epilepsy  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Headache  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Hypoaesthesia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Intracranial aneurysm  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ischaemic stroke  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Lumbar radiculopathy  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Parkinson's disease  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Seizure  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Syncope  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Transient ischaemic attack  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  1/181 (0.55%) 
Tremor  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Abortion spontaneous complete  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Product Issues           
Device dislocation  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Device loosening  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Psychiatric disorders           
Alcoholism  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Aversion  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Completed suicide  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Depression  1  3/545 (0.55%)  2/890 (0.22%)  5/1113 (0.45%)  0/150 (0.00%)  0/181 (0.00%) 
Hypomania  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Schizophrenia  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Substance abuse  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Suicidal ideation  1  0/545 (0.00%)  2/890 (0.22%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Suicide attempt  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Renal and urinary disorders           
Calculus urinary  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Chronic kidney disease  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Nephrolithiasis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Nephrotic syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pollakiuria  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ureterolithiasis  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Urethral stenosis  1  0/545 (0.00%)  0/890 (0.00%)  0/1113 (0.00%)  0/150 (0.00%)  1/181 (0.55%) 
Reproductive system and breast disorders           
Menorrhagia  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Ovarian cyst  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Vaginal cyst  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory distress syndrome  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Asthma  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Laryngeal oedema  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Nasal septum deviation  1  1/545 (0.18%)  2/890 (0.22%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Nasal turbinate hypertrophy  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pleural effusion  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pulmonary alveolar haemorrhage  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pulmonary embolism  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Pulmonary oedema  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Sinus polyp  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Sleep apnoea syndrome  1  2/545 (0.37%)  0/890 (0.00%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Skin and subcutaneous tissue disorders           
Angioedema  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Dermal cyst  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Dermatitis contact  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Diabetic foot  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Drug eruption  1  1/545 (0.18%)  0/890 (0.00%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Psoriasis  1  2/545 (0.37%)  3/890 (0.34%)  5/1113 (0.45%)  0/150 (0.00%)  0/181 (0.00%) 
Vascular disorders           
Circulatory collapse  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Hypertension  1  1/545 (0.18%)  1/890 (0.11%)  2/1113 (0.18%)  0/150 (0.00%)  0/181 (0.00%) 
Hypertensive crisis  1  0/545 (0.00%)  3/890 (0.34%)  3/1113 (0.27%)  0/150 (0.00%)  0/181 (0.00%) 
Hypotension  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
Varicose vein  1  0/545 (0.00%)  1/890 (0.11%)  1/1113 (0.09%)  0/150 (0.00%)  0/181 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Any AIN457 150 mg Any AIN457 300 mg Any AIN457 Dose AIN457 150 mg - Placebo AIN457 300 mg - Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   386/545 (70.83%)   679/890 (76.29%)   889/1113 (79.87%)   75/150 (50.00%)   86/181 (47.51%) 
Gastrointestinal disorders           
Abdominal pain upper  1  11/545 (2.02%)  15/890 (1.69%)  25/1113 (2.25%)  2/150 (1.33%)  1/181 (0.55%) 
Diarrhoea  1  29/545 (5.32%)  53/890 (5.96%)  81/1113 (7.28%)  3/150 (2.00%)  5/181 (2.76%) 
Gastritis  1  11/545 (2.02%)  21/890 (2.36%)  31/1113 (2.79%)  1/150 (0.67%)  0/181 (0.00%) 
Gastrooesophageal reflux disease  1  12/545 (2.20%)  25/890 (2.81%)  37/1113 (3.32%)  1/150 (0.67%)  0/181 (0.00%) 
Nausea  1  9/545 (1.65%)  15/890 (1.69%)  24/1113 (2.16%)  0/150 (0.00%)  0/181 (0.00%) 
Toothache  1  10/545 (1.83%)  33/890 (3.71%)  43/1113 (3.86%)  0/150 (0.00%)  2/181 (1.10%) 
General disorders           
Influenza like illness  1  24/545 (4.40%)  45/890 (5.06%)  65/1113 (5.84%)  2/150 (1.33%)  2/181 (1.10%) 
Pyrexia  1  7/545 (1.28%)  24/890 (2.70%)  31/1113 (2.79%)  0/150 (0.00%)  2/181 (1.10%) 
Immune system disorders           
Seasonal allergy  1  8/545 (1.47%)  19/890 (2.13%)  27/1113 (2.43%)  2/150 (1.33%)  1/181 (0.55%) 
Infections and infestations           
Bronchitis  1  31/545 (5.69%)  63/890 (7.08%)  92/1113 (8.27%)  3/150 (2.00%)  3/181 (1.66%) 
Conjunctivitis  1  10/545 (1.83%)  30/890 (3.37%)  38/1113 (3.41%)  1/150 (0.67%)  1/181 (0.55%) 
Cystitis  1  10/545 (1.83%)  23/890 (2.58%)  31/1113 (2.79%)  0/150 (0.00%)  1/181 (0.55%) 
Folliculitis  1  13/545 (2.39%)  18/890 (2.02%)  31/1113 (2.79%)  1/150 (0.67%)  2/181 (1.10%) 
Gastroenteritis  1  24/545 (4.40%)  35/890 (3.93%)  59/1113 (5.30%)  3/150 (2.00%)  2/181 (1.10%) 
Herpes zoster  1  3/545 (0.55%)  25/890 (2.81%)  27/1113 (2.43%)  2/150 (1.33%)  0/181 (0.00%) 
Influenza  1  24/545 (4.40%)  54/890 (6.07%)  78/1113 (7.01%)  4/150 (2.67%)  6/181 (3.31%) 
Nasopharyngitis  1  145/545 (26.61%)  271/890 (30.45%)  375/1113 (33.69%)  17/150 (11.33%)  21/181 (11.60%) 
Oral candidiasis  1  7/545 (1.28%)  22/890 (2.47%)  29/1113 (2.61%)  1/150 (0.67%)  0/181 (0.00%) 
Oral herpes  1  12/545 (2.20%)  25/890 (2.81%)  36/1113 (3.23%)  2/150 (1.33%)  2/181 (1.10%) 
Pharyngitis  1  18/545 (3.30%)  38/890 (4.27%)  55/1113 (4.94%)  1/150 (0.67%)  3/181 (1.66%) 
Rhinitis  1  11/545 (2.02%)  30/890 (3.37%)  38/1113 (3.41%)  0/150 (0.00%)  1/181 (0.55%) 
Sinusitis  1  18/545 (3.30%)  51/890 (5.73%)  64/1113 (5.75%)  4/150 (2.67%)  3/181 (1.66%) 
Tinea pedis  1  9/545 (1.65%)  29/890 (3.26%)  38/1113 (3.41%)  0/150 (0.00%)  2/181 (1.10%) 
Tonsillitis  1  19/545 (3.49%)  31/890 (3.48%)  49/1113 (4.40%)  6/150 (4.00%)  3/181 (1.66%) 
Tooth infection  1  10/545 (1.83%)  18/890 (2.02%)  28/1113 (2.52%)  0/150 (0.00%)  1/181 (0.55%) 
Upper respiratory tract infection  1  52/545 (9.54%)  119/890 (13.37%)  153/1113 (13.75%)  8/150 (5.33%)  12/181 (6.63%) 
Urinary tract infection  1  15/545 (2.75%)  33/890 (3.71%)  46/1113 (4.13%)  3/150 (2.00%)  2/181 (1.10%) 
Viral upper respiratory tract infection  1  11/545 (2.02%)  21/890 (2.36%)  31/1113 (2.79%)  0/150 (0.00%)  2/181 (1.10%) 
Injury, poisoning and procedural complications           
Contusion  1  9/545 (1.65%)  22/890 (2.47%)  31/1113 (2.79%)  1/150 (0.67%)  2/181 (1.10%) 
Laceration  1  9/545 (1.65%)  16/890 (1.80%)  25/1113 (2.25%)  1/150 (0.67%)  0/181 (0.00%) 
Ligament sprain  1  13/545 (2.39%)  21/890 (2.36%)  34/1113 (3.05%)  1/150 (0.67%)  2/181 (1.10%) 
Muscle strain  1  9/545 (1.65%)  17/890 (1.91%)  25/1113 (2.25%)  0/150 (0.00%)  1/181 (0.55%) 
Procedural pain  1  8/545 (1.47%)  21/890 (2.36%)  29/1113 (2.61%)  1/150 (0.67%)  0/181 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  13/545 (2.39%)  8/890 (0.90%)  21/1113 (1.89%)  1/150 (0.67%)  1/181 (0.55%) 
Metabolism and nutrition disorders           
Diabetes mellitus  1  3/545 (0.55%)  18/890 (2.02%)  20/1113 (1.80%)  1/150 (0.67%)  0/181 (0.00%) 
Hyperlipidaemia  1  11/545 (2.02%)  9/890 (1.01%)  20/1113 (1.80%)  2/150 (1.33%)  0/181 (0.00%) 
Hypertriglyceridaemia  1  11/545 (2.02%)  18/890 (2.02%)  29/1113 (2.61%)  2/150 (1.33%)  1/181 (0.55%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  47/545 (8.62%)  80/890 (8.99%)  124/1113 (11.14%)  8/150 (5.33%)  13/181 (7.18%) 
Back pain  1  40/545 (7.34%)  76/890 (8.54%)  114/1113 (10.24%)  4/150 (2.67%)  5/181 (2.76%) 
Musculoskeletal pain  1  14/545 (2.57%)  19/890 (2.13%)  33/1113 (2.96%)  0/150 (0.00%)  0/181 (0.00%) 
Myalgia  1  10/545 (1.83%)  22/890 (2.47%)  32/1113 (2.88%)  3/150 (2.00%)  1/181 (0.55%) 
Pain in extremity  1  20/545 (3.67%)  29/890 (3.26%)  49/1113 (4.40%)  2/150 (1.33%)  2/181 (1.10%) 
Psoriatic arthropathy  1  11/545 (2.02%)  38/890 (4.27%)  47/1113 (4.22%)  8/150 (5.33%)  6/181 (3.31%) 
Tendonitis  1  5/545 (0.92%)  23/890 (2.58%)  28/1113 (2.52%)  1/150 (0.67%)  1/181 (0.55%) 
Nervous system disorders           
Headache  1  36/545 (6.61%)  87/890 (9.78%)  116/1113 (10.42%)  4/150 (2.67%)  2/181 (1.10%) 
Psychiatric disorders           
Anxiety  1  8/545 (1.47%)  20/890 (2.25%)  28/1113 (2.52%)  1/150 (0.67%)  1/181 (0.55%) 
Depression  1  14/545 (2.57%)  10/890 (1.12%)  24/1113 (2.16%)  2/150 (1.33%)  2/181 (1.10%) 
Insomnia  1  11/545 (2.02%)  20/890 (2.25%)  30/1113 (2.70%)  2/150 (1.33%)  2/181 (1.10%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  27/545 (4.95%)  43/890 (4.83%)  66/1113 (5.93%)  1/150 (0.67%)  4/181 (2.21%) 
Oropharyngeal pain  1  23/545 (4.22%)  42/890 (4.72%)  65/1113 (5.84%)  3/150 (2.00%)  3/181 (1.66%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact  1  5/545 (0.92%)  19/890 (2.13%)  23/1113 (2.07%)  0/150 (0.00%)  0/181 (0.00%) 
Eczema  1  8/545 (1.47%)  34/890 (3.82%)  41/1113 (3.68%)  0/150 (0.00%)  2/181 (1.10%) 
Pruritus  1  11/545 (2.02%)  24/890 (2.70%)  34/1113 (3.05%)  2/150 (1.33%)  3/181 (1.66%) 
Psoriasis  1  14/545 (2.57%)  39/890 (4.38%)  51/1113 (4.58%)  1/150 (0.67%)  3/181 (1.66%) 
Vascular disorders           
Hypertension  1  42/545 (7.71%)  83/890 (9.33%)  119/1113 (10.69%)  5/150 (3.33%)  6/181 (3.31%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01544595     History of Changes
Other Study ID Numbers: CAIN457A2302E1
2012-000533-39
First Submitted: February 28, 2012
First Posted: March 6, 2012
Results First Submitted: June 25, 2018
Results First Posted: December 20, 2018
Last Update Posted: December 20, 2018