Extension Study up to 3 Years for Secukinumab in Psoriati... | NCT01892436

ID	Type	Description	Link
2013-001241-13	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secukinumab 75mg	Experimental	Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator	Drug: Secukinumab
Secukinumab 150mg	Experimental	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator	Drug: Secukinumab
Placebo - AIN457A 75mg	Experimental	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg	Drug: Secukinumab Drug: Placebo
Placebo - AIN457 150mg	Experimental	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg	Drug: Secukinumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Drug	Secukinumab is 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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20	Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: Patient's assessment of Psoriatic Arthritis (PsA) pain Patient's global assessment of disease activity Physician's global assessment of disease activity Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score) Acute phase reactant (hsCRP or ESR)	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR50	Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures: Patient's assessment of PsA pain Patient's global assessment of disease activity Physician's global assessment of disease activity Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score) Acute phase reactant (hsCRP or ESR)	weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR70	Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain Patient's global assessment of disease activity Physician's global assessment of disease activity Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score) Acute phase reactant (hsCRP or ESR)	weeks 116, 128, 140, 156, 180, 208, 232 and 260

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Anniston	Alabama	36207-5710	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30167329	Derived	Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Mpofu S, Pricop L. Secukinumab in the treatment of psoriatic arthritis: efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open. 2018 Aug 13;4(2):e000723. doi: 10.1136/rmdopen-2018-000723. eCollection 2018.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Secukinumab 75mg	Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
FG001	Secukinumab 150mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 22, 2016	Jan 10, 2019

Arm/Group Information

ID	Title	Description
BG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
BG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
BG002	Placebo - AIN457A 75mg	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
BG003	Placebo - AIN457 150mg	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Age groups are reported cumulatively so categories are not mutually exclusive.

Number

Count of Participants

Title

Denominators

Categories

<65

Title	Measurements
	BG000132 BG001145 BG00272 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00081 BG00183 BG002

Race/Ethnicity, Customized

Number

Count of participants

Title

Denominators

Categories

White

Title	Measurements
	BG000118 BG001130 BG002

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

Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20

Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

Patient's assessment of Psoriatic Arthritis (PsA) pain
Patient's global assessment of disease activity
Physician's global assessment of disease activity
Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
Acute phase reactant (hsCRP or ESR)

Extension Full Analysis Set (extension FAS) is comprised all patients enrolled in the extension study who had at least one post baseline assessment of efficacy during the extension period. Patients were analyzed according to the treatment they were assigned.

Posted

Number

95% Confidence Interval

percentage of participants

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG003	Placebo - AIN457 150mg	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg. Participants also received secukinumab 150 mg from week 16/24. patients may have been escalated to 300mg or 300 mg as judged appropriate by investigator

Units	Counts
Participants	OG000147 OG001161 OG00274 OG003

Title

Denominators

Categories

week 116

Title	Measurements
	OG00071.3(63.1 to 78.4) OG00173.9(66.0 to 80.5) OG00273.2(61.2 to 82.7) OG003

Primary

Proportion of Subjects Who Reached ACR50

Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:

Patient's assessment of PsA pain
Patient's global assessment of disease activity
Physician's global assessment of disease activity
Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
Acute phase reactant (hsCRP or ESR)

Extension FAS

Posted

Number

95% Confidence Interval

percentage of participants

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg

Primary

Proportion of Subjects Who Reached ACR70

Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain

Patient's global assessment of disease activity
Physician's global assessment of disease activity
Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
Acute phase reactant (hsCRP or ESR)

Extension FAS

Posted

Number

95% Confidence Interval

percentage of participants

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg

Secondary

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)

Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)

Extension FAS

Posted

Mean

Standard Deviation

change in scores

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg

Secondary

Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)

Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.

Extension FAS

Posted

Number

95% Confidence Interval

percentage of participants

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg

Secondary

Change From Baseline in Disease Activity Score-CRP (DAS28)

Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores.

DAS28 is a combined measure of disease activity based on the following formula:

DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score

Extension FAS

Posted

Mean

Standard Deviation

change in scores

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg

Secondary

Percentage of Subjects Achieving Low Disease Activity

Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission

Extension FAS

Posted

Number

95% Confidence Interval

percentage of participants

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator

Secondary

Percentage of Subjects Achieving Disease Remission (DAS28<2.6)

Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission

Posted

Number

95% Confidence Interval

percentage of participants

weeks 116, 128, 140, 156, 180, 208, 232 and 260

ID	Title	Description
OG000	Secukinumab 75mg	Subjects initially continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
OG001	Secukinumab 150mg	Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256. From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
OG002	Placebo - AIN457A 75mg	Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1.0 mL solution for injection was provided in PFS for s.c. administration (a single use pre-filled 1mL long glass syringe). It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg. Participants also received secukinumab 75mg from week 16/24. Patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG0030 affected202 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Coronary artery insufficiency	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Myocarditis	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Palpitations	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Basedow's disease	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Goitre	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Ocular myasthenia	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Aphthous ulcer	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Femoral hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Impaired healing	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0014 affected473 at risk EG0020 affected165 at risk EG003
Peripheral swelling	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Pyrexia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Chronic hepatitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Abscess limb	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Appendiceal abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Appendicitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Cellulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected292 at risk EG0014 affected473 at risk EG0020 affected165 at risk EG003
Dengue fever	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0013 affected473 at risk EG0020 affected165 at risk EG003
Erysipelas	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Klebsiella sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Lung abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected292 at risk EG0014 affected473 at risk EG0021 affected165 at risk EG003
Post procedural infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Prostatitis Escherichia coli	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Rash pustular	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Salpingo-oophoritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Septic shock	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Streptococcal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Typhoid fever	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0012 affected473 at risk EG0021 affected165 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Urosepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Viral infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Eyelid injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Periprosthetic osteolysis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0013 affected473 at risk EG0020 affected165 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Limb asymmetry	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected292 at risk EG0017 affected473 at risk EG0021 affected165 at risk EG003
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0015 affected473 at risk EG0020 affected165 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0021 affected165 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Intraductal papilloma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Laryngeal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Pleomorphic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Squamous cell carcinoma of pharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Dizziness	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Hemiplegia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Intracranial venous sinus thrombosis	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Presyncope	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Syncope	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Thrombotic stroke	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Depression	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0012 affected473 at risk EG0020 affected165 at risk EG003
Adenomyosis	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Adnexa uteri cyst	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Pelvic adhesions	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0013 affected473 at risk EG0021 affected165 at risk EG003
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0021 affected165 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected292 at risk EG0011 affected473 at risk EG0020 affected165 at risk EG003
Polyarteritis nodosa	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected292 at risk EG0010 affected473 at risk EG0020 affected165 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00023 affected292 at risk EG00138 affected473 at risk EG0021 affected165 at risk EG0036 affected202 at risk
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00017 affected292 at risk EG00114 affected473 at risk EG0023 affected165 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00015 affected292 at risk EG0018 affected473 at risk EG0020 affected165 at risk EG003
Bronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00024 affected292 at risk EG00135 affected473 at risk EG0029 affected165 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00010 affected292 at risk EG00130 affected473 at risk EG0022 affected165 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00070 affected292 at risk EG001101 affected473 at risk EG00214 affected165 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00015 affected292 at risk EG00122 affected473 at risk EG0020 affected165 at risk EG003
Sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00017 affected292 at risk EG00126 affected473 at risk EG0023 affected165 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00062 affected292 at risk EG00191 affected473 at risk EG00210 affected165 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00021 affected292 at risk EG00127 affected473 at risk EG0022 affected165 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00024 affected292 at risk EG00130 affected473 at risk EG0023 affected165 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00030 affected292 at risk EG00133 affected473 at risk EG0023 affected165 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00023 affected292 at risk EG00127 affected473 at risk EG0022 affected165 at risk EG003
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG00031 affected292 at risk EG00142 affected473 at risk EG0021 affected165 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG00021 affected292 at risk EG00130 affected473 at risk EG0023 affected165 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG00020 affected292 at risk EG00119 affected473 at risk EG0021 affected165 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG00023 affected292 at risk EG00123 affected473 at risk EG0022 affected165 at risk EG003
Hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG00027 affected292 at risk EG00133 affected473 at risk EG0027 affected165 at risk EG003

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D001168	Arthritis
D007592	Joint Diseases
D011565	Psoriasis
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 75 mg	Any AIN457 75 mg	3	292	48	292	197	292
EG001	Any AIN457 150 mg	Any AIN457 150 mg	3	473	96	473	264	473
EG002	Any AIN457 300 mg	Any AIN457 300 mg	0	165	10	165	47	165
EG003	Placebo	Placebo	0	202	11	202	63	202