Extension Study of Secukinumab Prefilled Syringes in Subj... | NCT01544595

ID	Type	Description	Link
2012-000533-39

Label	Type	Description	Intervention Names
PASI 75 Responders	Placebo Comparator	PASI 75 responders participated in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies were randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Participants on first full relapse received loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.	Drug: Secukinumab (AIN457) Drug: Placebo
Partial responders	Experimental	Partial responders were not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies did not participate in the randomized withdrawal. These subjects continued same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies.	Drug: Secukinumab (AIN457)

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab (AIN457)	Drug	Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.

Measure	Description	Time Frame
Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68	The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders.	At week 68 (16 weeks after week 52)

Measure	Description	Time Frame
Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period	Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab. PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement [reduction] in PASI score compared to baseline of the core study). PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders. PASI 100 response/remission: complete clearing of psoriasis (PASI=0)

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35205	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
36763857	Derived	Langley RG, Sofen H, Dei-Cas I, Reich K, Sigurgeirsson B, Warren RB, Paul C, Szepietowski JC, Tsai TF, Hampele I, You R, Charef P, Papavassilis C. Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials. Br J Dermatol. 2023 Feb 10;188(2):198-207. doi: 10.1093/bjd/ljac040.

ID	Title	Description
FG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
FG001	AIN457 300 mg -Randomized Withdrawal Period

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 29, 2015	Jun 25, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68

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

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

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

Full analysis set (FAS): patients from randomized set with at least 1 post baseline efficacy assessment.

Posted

Number

95% Confidence Interval

Cummulative rate

At week 68 (16 weeks after week 52)

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo

Units	Counts
Participants	OG000297 OG001363 OG002150 OG003

Title

Denominators

Categories

Title	Measurements
	OG00049.8(25.8 to 79.7) OG00125.4(9.8 to 56.5) OG00274.3(56.9 to 88.8) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	The following hypotheses were tested for 52 weeks≤ t ≤68 weeks H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0, H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,	Log Rank		<0.0001		Hazard Ratio (HR)	0.30			2-Sided	95	0.22	0.42					Superiority	H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68 • H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68

Secondary

Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period

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

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

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

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

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

FAS

Posted

Number

Number of participants

Week 52, 104, and 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period

Secondary

Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period

Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.

FAS

Posted

Number

Number of participants

Week 52, Week 104, Week 156, week 208, week 260

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period

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

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

FAS

Posted

Mean

Standard Deviation

Percent change in PASI score

Week 52, 104, and 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period

Secondary

Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period

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

FAS

Posted

Mean

Standard Deviation

Percent change in PASI score

Week 52, Week 104, Week 156, week 208, week 260

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period

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

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

FAS

Posted

Number

Number of participants

Week 52 (baseline), 104, and 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period

Secondary

Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period

Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)

FAS

Posted

Number

Number of participants

Week 52, Week 104, Week 156, week 208, week 260

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period

Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.

FAS

Posted

Number

Number of participants

Week 52, Week 104, Week 156, week 208, week 260

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period

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

time = 0 refers to Week 52

FAS

Posted

Number

95% Confidence Interval

Percent of participants

Week 68

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo

Secondary

Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse

PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52

FAS

Posted

Number

95% Confidence Interval

Percent of participants

up to week 260

ID	Title	Description
OG000	Placebo - AIN457 150 mg	Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed
OG001	Placebo - AIN457 300 mg	Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed

Units	Counts
Participants	OG000

Secondary

Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse

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

time = 0 refers to Week 52

FAS

Posted

Number

95% Confidence Interval

Percent of participants

up to week 260

ID	Title	Description
OG000	Placebo - AIN457 150 mg	Patients randomized to placebo at Week 52, treated with AIN457 150mg after they relapsed
OG001	Placebo - AIN457 300 mg	Patients randomized to placebo at Week 52, treated with AIN457 300mg after they relapsed

Units	Counts
Participants	OG000

Secondary

Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period

Time 0 = week 52

FAS

Posted

Number

95% Confidence Interval

Percent of participants with relapses

up to week 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo

Secondary

Percent of Participants With Relapse After Last Injection

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

Time 0 = week 52

FAS

Posted

Number

95% Confidence Interval

Percent of participants with relapse

up to week 16

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

Percent of Participants With Rebound After Last Injection

Rebound: PASI increases to > 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of > 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.

FAS

Posted

Number

95% Confidence Interval

Percent of participants with rebound

up to week 68

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants

Secondary

Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)

Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.

FAS

Posted

Number

Number of participants

Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo

Secondary

Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period

Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.

FAS

Posted

Number

Number of participants

Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period

EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.

FAS

Posted

Mean

Standard Deviation

Percent change

Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo

Secondary

EQ-5D Health State Assessment (Observed Value) - Entire Study Period

FAS

Posted

Mean

Standard Deviation

Percent change

week 64, 76, 88, 104, 116, 128, 140, and 156

ID	Title	Description
OG000	AIN457 150 mg Only	patients staying strictly on AIN457 150mg from Week 52
OG001	AIN457 300 mg Only	Patients staying strictly on AIN457 300mg from Week 52

Units	Counts
Participants	OG000

Secondary

Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period

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

IR=incidence rate per 100 subject years

Safety set

Posted

Number

95% Confidence Interval

Week 52-156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period

Secondary

Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period

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

Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were be analyzed according to treatment received.

Posted

Number

Participants

approximately 4 years

ID	Title	Description
OG000	Any AIN457 150 mg	Safety data from patients while on AIN457 150 mg
OG001	Any AIN457 300 mg	Safety data from patients while on AIN457 300 mg
OG002	Any AIN457	safety data from patients while on any dose of AIN457

Units	Counts
Participants

Secondary

Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period

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

IR=incidence rate per 100 subject years.

Safety set

Posted

Number

95% Confidence Interval

Week 52 - 156

ID	Title	Description
OG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
OG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
OG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
OG003	AIN457 300 mg Placebo - Randomized Withdrawal Period

Secondary

Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period

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

Safety set

Posted

Number

Participants

Approximately 4 years

ID	Title	Description
OG000	Any AIN457 150 mg	Safety data from patients while on AIN457 150 mg
OG001	Any AIN457 300 mg	Safety data from patients while on AIN457 300 mg
OG002	Any AIN457	safety data from patients while on any dose of AIN457

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG0030 affected150 at risk EG0040 affected181 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0014 affected890 at risk EG0024 affected1,113 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0014 affected890 at risk EG0024 affected1,113 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0019 affected890 at risk EG00210 affected1,113 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0013 affected890 at risk EG0024 affected1,113 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0012 affected890 at risk EG0023 affected1,113 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Tachycardia paroxysmal	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Malformation venous	Congenital, familial and genetic disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Hyperandrogenism	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cataract	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Retinal detachment	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Asthenia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Chest discomfort	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Face oedema	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Impaired healing	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Medical device site granuloma	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0011 affected890 at risk EG0023 affected1,113 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Abscess limb	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Abscess neck	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Appendicitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0012 affected890 at risk EG0024 affected1,113 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cellulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Chronic tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Device related infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected545 at risk EG0011 affected890 at risk EG0024 affected1,113 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Epididymitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Erysipelas	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Escherichia infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Gallbladder empyema	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Graft infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Hepatitis A	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Implant site infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Localised infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Oophoritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Otitis media	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Peritonitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0014 affected890 at risk EG0025 affected1,113 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Post procedural infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Rhinitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0014 affected890 at risk EG0024 affected1,113 at risk EG003
Septic shock	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Streptococcal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Tick-borne viral encephalitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0012 affected890 at risk EG0024 affected1,113 at risk EG003
Tooth infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Viral pericarditis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Wound infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0011 affected890 at risk EG0023 affected1,113 at risk EG003
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0013 affected890 at risk EG0023 affected1,113 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Kidney rupture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0012 affected890 at risk EG0023 affected1,113 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0013 affected890 at risk EG0023 affected1,113 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0013 affected890 at risk EG0023 affected1,113 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0012 affected890 at risk EG0023 affected1,113 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0012 affected890 at risk EG0023 affected1,113 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0014 affected890 at risk EG0025 affected1,113 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0011 affected890 at risk EG0023 affected1,113 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Complex regional pain syndrome	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Cranial nerve paralysis	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Drooling	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Seizure	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Syncope	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Tremor	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Abortion spontaneous complete	Pregnancy, puerperium and perinatal conditions	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Device dislocation	Product Issues	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Device loosening	Product Issues	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Aversion	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Depression	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected545 at risk EG0012 affected890 at risk EG0025 affected1,113 at risk EG003
Hypomania	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Substance abuse	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0012 affected890 at risk EG0022 affected1,113 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0010 affected890 at risk EG0020 affected1,113 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Vaginal cyst	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0012 affected890 at risk EG0023 affected1,113 at risk EG003
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0010 affected890 at risk EG0022 affected1,113 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0010 affected890 at risk EG0021 affected1,113 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected545 at risk EG0013 affected890 at risk EG0025 affected1,113 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected545 at risk EG0011 affected890 at risk EG0022 affected1,113 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0013 affected890 at risk EG0023 affected1,113 at risk EG003
Hypotension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003
Varicose vein	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected545 at risk EG0011 affected890 at risk EG0021 affected1,113 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00115 affected890 at risk EG00225 affected1,113 at risk EG0032 affected150 at risk EG0041 affected181 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00029 affected545 at risk EG00153 affected890 at risk EG00281 affected1,113 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00121 affected890 at risk EG00231 affected1,113 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00012 affected545 at risk EG00125 affected890 at risk EG00237 affected1,113 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected545 at risk EG00115 affected890 at risk EG00224 affected1,113 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00010 affected545 at risk EG00133 affected890 at risk EG00243 affected1,113 at risk EG003
Influenza like illness	General disorders	MedDRA (20.1)	Systematic Assessment	EG00024 affected545 at risk EG00145 affected890 at risk EG00265 affected1,113 at risk EG003
Pyrexia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected545 at risk EG00124 affected890 at risk EG00231 affected1,113 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected545 at risk EG00119 affected890 at risk EG00227 affected1,113 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00031 affected545 at risk EG00163 affected890 at risk EG00292 affected1,113 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00010 affected545 at risk EG00130 affected890 at risk EG00238 affected1,113 at risk EG003
Cystitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00010 affected545 at risk EG00123 affected890 at risk EG00231 affected1,113 at risk EG003
Folliculitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00013 affected545 at risk EG00118 affected890 at risk EG00231 affected1,113 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00024 affected545 at risk EG00135 affected890 at risk EG00259 affected1,113 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected545 at risk EG00125 affected890 at risk EG00227 affected1,113 at risk EG003
Influenza	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00024 affected545 at risk EG00154 affected890 at risk EG00278 affected1,113 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG000145 affected545 at risk EG001271 affected890 at risk EG002375 affected1,113 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0007 affected545 at risk EG00122 affected890 at risk EG00229 affected1,113 at risk EG003
Oral herpes	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00012 affected545 at risk EG00125 affected890 at risk EG00236 affected1,113 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00018 affected545 at risk EG00138 affected890 at risk EG00255 affected1,113 at risk EG003
Rhinitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00130 affected890 at risk EG00238 affected1,113 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00018 affected545 at risk EG00151 affected890 at risk EG00264 affected1,113 at risk EG003
Tinea pedis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0009 affected545 at risk EG00129 affected890 at risk EG00238 affected1,113 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00019 affected545 at risk EG00131 affected890 at risk EG00249 affected1,113 at risk EG003
Tooth infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00010 affected545 at risk EG00118 affected890 at risk EG00228 affected1,113 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00052 affected545 at risk EG001119 affected890 at risk EG002153 affected1,113 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00015 affected545 at risk EG00133 affected890 at risk EG00246 affected1,113 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00121 affected890 at risk EG00231 affected1,113 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0009 affected545 at risk EG00122 affected890 at risk EG00231 affected1,113 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0009 affected545 at risk EG00116 affected890 at risk EG00225 affected1,113 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG00013 affected545 at risk EG00121 affected890 at risk EG00234 affected1,113 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0009 affected545 at risk EG00117 affected890 at risk EG00225 affected1,113 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0008 affected545 at risk EG00121 affected890 at risk EG00229 affected1,113 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG00013 affected545 at risk EG0018 affected890 at risk EG00221 affected1,113 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected545 at risk EG00118 affected890 at risk EG00220 affected1,113 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG0019 affected890 at risk EG00220 affected1,113 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00118 affected890 at risk EG00229 affected1,113 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00047 affected545 at risk EG00180 affected890 at risk EG002124 affected1,113 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00040 affected545 at risk EG00176 affected890 at risk EG002114 affected1,113 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00014 affected545 at risk EG00119 affected890 at risk EG00233 affected1,113 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00010 affected545 at risk EG00122 affected890 at risk EG00232 affected1,113 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00020 affected545 at risk EG00129 affected890 at risk EG00249 affected1,113 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00138 affected890 at risk EG00247 affected1,113 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected545 at risk EG00123 affected890 at risk EG00228 affected1,113 at risk EG003
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG00036 affected545 at risk EG00187 affected890 at risk EG002116 affected1,113 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected545 at risk EG00120 affected890 at risk EG00228 affected1,113 at risk EG003
Depression	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG00014 affected545 at risk EG00110 affected890 at risk EG00224 affected1,113 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00120 affected890 at risk EG00230 affected1,113 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG00027 affected545 at risk EG00143 affected890 at risk EG00266 affected1,113 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG00023 affected545 at risk EG00142 affected890 at risk EG00265 affected1,113 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected545 at risk EG00119 affected890 at risk EG00223 affected1,113 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected545 at risk EG00134 affected890 at risk EG00241 affected1,113 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected545 at risk EG00124 affected890 at risk EG00234 affected1,113 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00014 affected545 at risk EG00139 affected890 at risk EG00251 affected1,113 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG00042 affected545 at risk EG00183 affected890 at risk EG002119 affected1,113 at risk EG003

ID	Title	Description
BG000	AIN457 150 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to AIN150 mg
BG001	AIN457 300 mg -Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to AIN300 mg
BG002	AIN457 150 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 150 mg in core study and randomized to placebo
BG003	AIN457 300 mg Placebo - Randomized Withdrawal Period	PASI 75 responders at Week 52, treated with AIN 300 mg in core study and randomized to placebo
BG004	AIN457 150 mg - Partial Responders	PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 150 mg in core and extension study
BG005	AIN457 300 mg - Partial Responders	PASI 50 responders / PASI 75 non responders at Week 52, treated with AIN 300 mg in core and extension study
BG006	Total	Total of all reporting groups

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Any AIN457 150 mg	safety data from patients while on AIN457 150 mg	0	545	61	545	386	545
EG001	Any AIN457 300 mg	safety data from patients while on AIN457 300 mg	2	890	143	890	679	890
EG002	Any AIN457 Dose	safety data from patients while on any dose of AIN457	2	1,113	198	1,113	889	1,113
EG003	AIN457 150 mg - Placebo	safety data from patients of corresponding randomized withdrawal group while on placebo	0	150	4	150	75	150
EG004	AIN457 300 mg - Placebo	safety data from patients of corresponding randomized withdrawal group while on placebo	0	181	13	181	86	181