Trial Outcomes & Findings for Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis (NCT NCT02474069)

Last Updated: 2019-07-05

Results Overview

Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

772 participants

Primary outcome timeframe

at 32 weeks

Results posted on

2019-07-05

Participant Flow

860 screened (not shown here). In selection phase (SP), 772 received 300 mg s.c. open-label secukinumab at baseline to wk 12. Those who did not achieve ≥Psoriasis Area and Severity Index (PASI) 75 at wk 16 discontinued. Those who had ≤ clear or almost clear skin (≥PASI75 but not PASI90) rolled over into double blind comparative dosing phase (CDP).

and randomized 1:1 to: a.standard treatment: 300 mg s.c. secukinumab treatment every 4 weeks (weeks 16, 20, 24, \& 28) and, to maintain the blind, placebo every 4 weeks b. OR dosage interval shortening: 300 mg s.c. secukinumab treatment every 2 weeks Those who achieved at least clear or almost clear skin (≥ PASI 90) at week 16 discontinued study

Participant milestones

Participant milestones
Measure	SP - Secukinumab 300 mg s.c. (4-weekly) In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.	CDP - Secukinumab 300 mg s.c. (4-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Selection Phase (SP) STARTED	772	0	0
Selection Phase (SP) COMPLETED	749	0	0
Selection Phase (SP) NOT COMPLETED	23	0	0
Comparative Dosing Phase (CDP) STARTED	0	162	163
Comparative Dosing Phase (CDP) COMPLETED	0	153	157
Comparative Dosing Phase (CDP) NOT COMPLETED	0	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	SP - Secukinumab 300 mg s.c. (4-weekly) In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.	CDP - Secukinumab 300 mg s.c. (4-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Selection Phase (SP) Adverse Event	8	0	0
Selection Phase (SP) Lack of Efficacy	1	0	0
Selection Phase (SP) Lost to Follow-up	4	0	0
Selection Phase (SP) Physician Decision	1	0	0
Selection Phase (SP) Protocol Violation	1	0	0
Selection Phase (SP) No longer requires treatment	1	0	0
Selection Phase (SP) Technical Problem	1	0	0
Selection Phase (SP) Withdrawal by Subject	3	0	0
Selection Phase (SP) Withdrawal of Informed Consent	3	0	0
Comparative Dosing Phase (CDP) Adverse Event	0	3	2
Comparative Dosing Phase (CDP) Lost to Follow-up	0	4	1
Comparative Dosing Phase (CDP) Withdrawal by Subject	0	0	1
Comparative Dosing Phase (CDP) Withdrawal of informed Consent	0	2	2

Baseline Characteristics

Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SP - Secukinumab 300 mg s.c. (4-weekly n=772 Participants In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16
Age, Continuous	45.8 Years STANDARD_DEVIATION 13.72 • n=5 Participants
Sex/Gender, Customized Female	222 Participants n=5 Participants
Sex/Gender, Customized Male	550 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 32 weeks

Population: Full Analysis Set (FAS) - Comparative Dosing Phase (CDP): consisted of all patients who were randomized and received at least one dose of study drug during the CDP and had at least one post-randomization assessment. Patients with missing PASI at week 32 were counted as non-responders, unless they were responders already at their last reported PASI.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Number of Participants With PASI 90 Response at Week 32	93 participants	105 participants

PRIMARY outcome

Timeframe: at week 32

Population: PPS: consisted of all patients from the FAS-CDP who completed the study without any major protocol deviation.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=136 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=134 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Number of Participants With PASI 90 Response at Week 32 for PPS	81 participants	85 participants

SECONDARY outcome

Timeframe: at weeks 1, 2, 3, 4, 8, 12 and 16

Population: FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.

Number of participants with at least 50, 75, 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=772 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 2, PASI 50	232 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 1, PASI 50	43 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 1, PASI 75	3 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 1, PASI 90	0 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 1, PASI 100	0 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 week 2, PASI 75	25 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 2, PASI 90	5 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 2, PASI 100	1 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 3, PASI 50	468 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 3, PASI 75	128 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 3, PASI 90	22 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 3, PASI 100	3 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 4, PASI 50	591 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 4, PASI 75	281 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 4, PASI 90	71 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 4, PASI 100	12 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 8, PASI 50	718 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 8, PASI 75	538 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 8, PASI 90	266 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 8, PASI 100	70 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 12, PASI 50	733 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 12, PASI 75	611 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 12, PASI 90	370 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 12, PASI 100	110 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 16, PASI 50	732 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 16, PASI 75	698 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 16, PASI 90	363 Number of participants	—
Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100 Week 16, PASI 100	124 Number of participants	—

SECONDARY outcome

Timeframe: at weeks 18, 22, 30, 32

Population: FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.

Number of participants with at least 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 18, PASI 90	42 Number of participants	36 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 18, PASI 100	1 Number of participants	1 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 22, PASI 90	70 Number of participants	67 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 22, PASI 100	9 Number of participants	9 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 26, PASI 90	85 Number of participants	94 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 26, PASI 100	9 Number of participants	14 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 30, PASI 90	93 Number of participants	104 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 30, PASI 100	17 Number of participants	19 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 32, PASI 90	93 Number of participants	105 Number of participants
Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100 Week 32, PASI 100	22 Number of participants	26 Number of participants

SECONDARY outcome

Timeframe: at weeks 1,2,3,4,8, 12, 16

Population: FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.

PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=772 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Selection Phase:Summary of PASI Total Score week 1	18.78 Score on a Scale Standard Deviation 9.629	—
Selection Phase:Summary of PASI Total Score week 2	14.32 Score on a Scale Standard Deviation 8.435	—
Selection Phase:Summary of PASI Total Score week 3	10.69 Score on a Scale Standard Deviation 7.372	—
Selection Phase:Summary of PASI Total Score week 4	8.12 Score on a Scale Standard Deviation 6.494	—
Selection Phase:Summary of PASI Total Score week 8	4.41 Score on a Scale Standard Deviation 4.544	—
Selection Phase:Summary of PASI Total Score Week 12	3.34 Score on a Scale Standard Deviation 3.833	—
Selection Phase:Summary of PASI Total Score Week 16	2.90 Score on a Scale Standard Deviation 3.816	—

SECONDARY outcome

Timeframe: Weeks 18, 22, 26, 30 and 32

Population: FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Comparative Dose Phase: Summary of PASI Total Score Week 18	3.71 Score on a Scale Standard Deviation 2.532	3.59 Score on a Scale Standard Deviation 2.595
Comparative Dose Phase: Summary of PASI Total Score Week 22	3.24 Score on a Scale Standard Deviation 2.947	3.07 Score on a Scale Standard Deviation 2.726
Comparative Dose Phase: Summary of PASI Total Score Week 26	2.85 Score on a Scale Standard Deviation 2.852	2.68 Score on a Scale Standard Deviation 3.393
Comparative Dose Phase: Summary of PASI Total Score Week 30	2.83 Score on a Scale Standard Deviation 3.339	2.34 Score on a Scale Standard Deviation 2.812
Comparative Dose Phase: Summary of PASI Total Score Week 32	2.84 Score on a Scale Standard Deviation 3.552	2.11 Score on a Scale Standard Deviation 2.701

SECONDARY outcome

Timeframe: Weeks 4, 16, 18, 22, 26, 30, 32

Population: FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.

The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. The DLQI was designed to assess health-related quality of life (HRQoL) in adult patients with skin diseases including psoriasis.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP Week 18	65 participants with DLQI score 0/1	58 participants with DLQI score 0/1
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP Week 22	70 participants with DLQI score 0/1	73 participants with DLQI score 0/1
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP Week 26	69 participants with DLQI score 0/1	83 participants with DLQI score 0/1
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP Week 30	75 participants with DLQI score 0/1	89 participants with DLQI score 0/1
Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP Week 32	82 participants with DLQI score 0/1	96 participants with DLQI score 0/1

SECONDARY outcome

Timeframe: Weeks 4, 16, 18, 22, 26, 30, 32

Population: FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Number of Patients Achieving DLQI Total Score <= 5 in the CDP Week 18	109 participants	108 participants
Number of Patients Achieving DLQI Total Score <= 5 in the CDP Week 22	112 participants	117 participants
Number of Patients Achieving DLQI Total Score <= 5 in the CDP Week 26	116 participants	121 participants
Number of Patients Achieving DLQI Total Score <= 5 in the CDP Week 30	114 participants	127 participants
Number of Patients Achieving DLQI Total Score <= 5 in the CDP Week 32	117 participants	126 participants

SECONDARY outcome

Timeframe: Weeks 4, 16

Population: FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.

The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=772 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 4	150 Participants	—
Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 16	446 Participants	—

SECONDARY outcome

Timeframe: Weeks 18, 22, 26, 30, 32

Population: FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 18	67 Participants	68 Participants
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 22	88 Participants	90 Participants
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 26	87 Participants	111 Participants
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 30	97 Participants	106 Participants
Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1 week 32	98 Participants	111 Participants

SECONDARY outcome

Timeframe: Weeks 4, 16

Population: FAS-CDPFAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=772 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Selection Phase: Summary of IGA Score Week 4	2.10 Score on a scale Standard Deviation 0.790	—
Selection Phase: Summary of IGA Score Week 16	1.26 Score on a scale Standard Deviation 0.875	—

SECONDARY outcome

Timeframe: Weeks 18, 22, 26, 30, 32

Population: FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.

Outcome measures

Outcome measures
Measure	CDP - Secukinumab 300 mg s.c. (4-weekly) n=162 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP - Secukinumab 300 mg s.c. (2-weekly) n=163 Participants In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Comparative Dose Phase:Summary of IGA Score Week 18	1.63 Score on a scale Standard Deviation 0.619	1.64 Score on a scale Standard Deviation 0.656
Comparative Dose Phase:Summary of IGA Score Week 22	1.46 Score on a scale Standard Deviation 0.733	1.42 Score on a scale Standard Deviation 0.704
Comparative Dose Phase:Summary of IGA Score Week 26	1.48 Score on a scale Standard Deviation 0.758	1.30 Score on a scale Standard Deviation 0.759
Comparative Dose Phase:Summary of IGA Score Week 30	1.33 Score on a scale Standard Deviation 0.848	1.27 Score on a scale Standard Deviation 0.803
Comparative Dose Phase:Summary of IGA Score Week 32	1.30 Score on a scale Standard Deviation 0.925	1.13 Score on a scale Standard Deviation 0.819

Adverse Events

SP-Secukinumab: AIN457 300 mg s.c. (4-weekly)

Serious events: 32 serious events

Other events: 510 other events

Deaths: 0 deaths

CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly)

Serious events: 8 serious events

Other events: 85 other events

Deaths: 0 deaths

CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)

Serious events: 4 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: (862) 778-8300

Email: [email protected]

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

Serious adverse events
Measure	SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) n=772 participants at risk In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.	CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) n=162 participants at risk In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly) n=163 participants at risk In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Cardiac disorders ATRIAL FIBRILLATION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Cardiac disorders CARDIAC FAILURE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Cardiac disorders MYOCARDITIS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders COLITIS ULCERATIVE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders DIARRHOEA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders GASTRITIS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders UMBILICAL HERNIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders CHEST PAIN	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders CHILLS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders IMPAIRED HEALING	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Hepatobiliary disorders BILIARY COLIC	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Infections and infestations ERYSIPELAS	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Infections and infestations MASTOIDITIS	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Infections and infestations PYODERMA	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Infections and infestations SINUSITIS	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Infections and infestations TONSILLITIS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Infections and infestations VARICELLA	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications CHEST INJURY	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications CONCUSSION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications CONTUSION	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications FALL	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications LIGAMENT RUPTURE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications RADIAL HEAD DISLOCATION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.26% 2/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications STERNAL FRACTURE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications TENDON RUPTURE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Injury, poisoning and procedural complications WOUND	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Investigations HEPATIC ENZYME INCREASED	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Musculoskeletal and connective tissue disorders SPINAL OSTEOARTHRITIS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.

Other adverse events
Measure	SP-Secukinumab: AIN457 300 mg s.c. (4-weekly) n=772 participants at risk In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.	CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly) n=162 participants at risk In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly) n=163 participants at risk In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
Gastrointestinal disorders VASCULITIS GASTROINTESTINAL	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders VOMITING	0.39% 3/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
General disorders APPLICATION SITE HAEMATOMA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders ASTHENIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders CHILLS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
General disorders DRUG THERAPEUTIC INCOMPATIBILITY	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
General disorders FATIGUE	3.6% 28/772 • 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 1 year and 4 months.	2.5% 4/162 • 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 1 year and 4 months.	1.8% 3/163 • 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 1 year and 4 months.
General disorders FEELING HOT	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Respiratory, thoracic and mediastinal disorders COUGH	1.6% 12/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	1.2% 2/163 • 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 1 year and 4 months.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.39% 3/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders TONGUE COATED	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders TONGUE DISCOLOURATION	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Gastrointestinal disorders TOOTHACHE	1.2% 9/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders GASTRITIS	0.65% 5/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Gastrointestinal disorders GASTRITIS EROSIVE	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Gastrointestinal disorders GASTROINTESTINAL PAIN	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders POUCHITIS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.78% 6/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Gastrointestinal disorders GINGIVAL DISORDER	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders GINGIVAL EROSION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders HAEMORRHOIDS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders HYPOAESTHESIA ORAL	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders INTRA-ABDOMINAL HAEMATOMA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders LIP BLISTER	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Gastrointestinal disorders LIP DRY	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders MALLORY-WEISS SYNDROME	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders MOUTH SWELLING	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders MOUTH ULCERATION	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders NAUSEA	1.2% 9/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Gastrointestinal disorders PARAESTHESIA ORAL	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.26% 2/772 • 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 1 year and 4 months.	1.2% 2/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Blood and lymphatic system disorders LYMPHOPENIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Blood and lymphatic system disorders NEUTROPENIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.00% 0/163 • 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 1 year and 4 months.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.13% 1/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/772 • 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 1 year and 4 months.	0.62% 1/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.00% 0/772 • 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 1 year and 4 months.	0.00% 0/162 • 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 1 year and 4 months.	0.61% 1/163 • 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 1 year and 4 months.