Secukinumab Dosage Optimisation in Partial Responders Wit... | NCT02474069

ID	Type	Description	Link
2014-001974-32	EudraCT Number

Label	Type	Description	Intervention Names
Secukinumab Interval Shortening	Active Comparator		Drug: Secukinumab
Secukinumab 4-weekly	Active Comparator		Drug: Secukinumab

Name	Type	Description	Arm Group Labels	Other Names
Secukinumab	Drug		Secukinumab 4-weekly Secukinumab Interval Shortening

Measure	Description	Time Frame
Number of Participants With PASI 90 Response at Week 32	Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).	at 32 weeks
Number of Participants With PASI 90 Response at Week 32 for PPS	Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).	at week 32

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects eligible for inclusion in this study must fulfill all of the following criteria:

Subjects must be able to understand and communicate with the investigator and must give a written, signed and dated informed consent before any study related activity is performed and who are willing and capable to comply with all study procedures.
Men or women at least 18 years of age at time of screening.
Chronic plaque type psoriasis diagnosed for at least 6 months prior to baseline
Moderate to severe plaque type psoriasis at baseline derived from the European consensus (Mrowietz et al., 2011): BSA (Body Surface Area) >10% and PASI>10 and DLQI>10.
Candidates for biologic therapy who failed to respond to, or who had a contraindication to or were intolerant to previous conventional systemic therapies.
According to local guidelines, to exclude chest infection before initiation of a biologic immunomodulating therapy, it is necessary to have obtained an image of the chest (X-ray, computerized tomography or magnetic resonance imaging) within 12 weeks prior to screening and have this evaluated by a qualified physician.

Exclusion Criteria:

Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttata psoriasis).
Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium).
Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to.
Subjects not willing to limit UV light exposure (e.g., sunbathing and/or the use of tanning devices) during the course of the study.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17A or the IL-17A receptor (e.g. brodalumab, ixekizumab).
History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Study personnel or first degree relatives of investigator(s) must not be included in the study.
Women who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)) who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion

*definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post- surgical bilateral oophorectomy with or without hysterectomy

**examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynakologie und Geburtshilfe:
- hormonal oral contraception (Combination of estrogen and gestagen, PI=0.1-0.9) hormonal vaginal ring (combination of estrogen and gestagen, PI=0.65 uncorr.; 0.4 corr.)
- hormonal transdermal patch (combination of estrogen and gestagen, PI= 0.72 uncorr.; 0.9 corr.)
- Estrogen-free ovulation inhibitors containing desogestrel (PI=0.14)
- Implanted hormones containing etonogestrel (PI=0-0.08)
- Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
- Intra-uterine progestine device (synthetic progestin containing IUDs,PI=0.16)
- Oral contraceptives without estrogen (e.g. "mini-pills"), nonsynthetic progesterone only IUDs, female condoms, cervical shield, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. Patients with psoriatic arthritis are not excluded.
Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
Subjects with preexisting or recent-onset central or peripheral nervous system demyelinating disorders at discretion of the investigator.
Significant medical problems, including but not limited to the following: uncontrolled hypertension (≥160 systolic and/or 95 diastolic mmHg), congestive heart failure [New York Heart Association status of class III or IV].
Subjects with a serum creatinine level exceeding 2.0 mg/dl (176.8μmol/l) at screening.
Screening total white blood cell (WBC) count <2,500/μl, or platelets <100,000/μl or neutrophils <1,500/μl or hemoglobin <8.5 g/dl.
Active systemic infections during the last two weeks (exception: common cold) prior to screening or any infection that reoccurs on a regular basis.
History of an ongoing, chronic or recurrent infectious disease including recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test at screening. Subjects with a positive or indeterminate QuantiFERON TB-Gold test may participate in the study if further full tuberculosis work up (according to local practice/guidelines) completed at least 12 weeks prior to first study drug administration establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines for at least 4 weeks prior to screening.
Past medical history record of infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to screening.
History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
Inability or unwillingness to undergo repeated venipuncture (e.g. because of poor tolerability or lack of access to veins).
Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
History or evidence of ongoing alcohol or drug abuse, within the last six months before screening.
Plans for administration of live vaccines during the study period or 6 weeks prior to screening.

No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects.

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Bad Bentheim		48455	Germany
Novartis Investigative Site

ID	Title	Description
FG000	SP - Secukinumab 300 mg s.c. (4-weekly)	In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
FG001	CDP - Secukinumab 300 mg s.c. (4-weekly)

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

Number of Participants With PASI 90 Response at Week 32

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

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

Posted

Number

participants

at 32 weeks

ID	Title	Description
OG000	CDP - Secukinumab 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Units	Counts
Participants	OG000162 OG001163

Title

Denominators

Categories

Title	Measurements
	OG00093 OG001105

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 OG001	Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error	ANCOVA		0.087		Odds Ratio (OR)	0.64			2-Sided	95	0.39	1.07					Superiority or Other

Primary

Number of Participants With PASI 90 Response at Week 32 for PPS

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

Posted

Number

participants

at week 32

ID	Title	Description
OG000	CDP - Secukinumab 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Secondary

Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100

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

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

Posted

Number

Number of participants

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

ID	Title	Description
OG000	SP - Secukinumab 300 mg s.c. (4-weekly)	In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.

Units	Counts
Participants

Secondary

Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100

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

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

Posted

Number

Number of participants

at weeks 18, 22, 30, 32

ID	Title	Description
OG000	CDP - Secukinumab 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Secondary

Selection Phase:Summary of PASI Total Score

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

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

Posted

Mean

Standard Deviation

Score on a Scale

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

ID	Title	Description
OG000	SP - Secukinumab 300 mg s.c. (4-weekly)	In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.

Units	Counts
Participants	OG000

Secondary

Comparative Dose Phase: Summary of PASI Total Score

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

Posted

Mean

Standard Deviation

Score on a Scale

Weeks 18, 22, 26, 30 and 32

ID	Title	Description
OG000	CDP - Secukinumab 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Secondary

Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP

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

The DLQI was designed to assess health-related quality of life (HRQoL) in adult patients with skin diseases including psoriasis.

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

Posted

Number

participants with DLQI score 0/1

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

ID	Title	Description
OG000	Secukinumab 300 mg s.c. (4-weekly)	Patients received 300 mg s.c. secukinumab treatment every 4 weeks and placebo every 4 weeks
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Secondary

Number of Patients Achieving DLQI Total Score <= 5 in the CDP

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

Posted

Number

participants

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

ID	Title	Description
OG000	Secukinumab 300 mg s.c. (4-weekly)	Patients received 300 mg s.c. secukinumab treatment every 4 weeks and placebo every 4 weeks.
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Secondary

Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1

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

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

Posted

Number

Participants

Weeks 4, 16

ID	Title	Description
OG000	SP - Secukinumab 300 mg s.c. (4-weekly)	In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.

Units	Counts
Participants	OG000

Secondary

Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1

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

Posted

Number

Participants

Weeks 18, 22, 26, 30, 32

ID	Title	Description
OG000	CDP - Secukinumab 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Units	Counts
Participants

Secondary

Selection Phase: Summary of IGA Score

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

Posted

Mean

Standard Deviation

Score on a scale

Weeks 4, 16

ID	Title	Description
OG000	SP - Secukinumab 300 mg s.c. (4-weekly)	In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.

Units	Counts
Participants	OG000

Secondary

Comparative Dose Phase:Summary of IGA Score

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

Posted

Mean

Standard Deviation

Score on a scale

Weeks 18, 22, 26, 30, 32

ID	Title	Description
OG000	CDP - Secukinumab 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
OG001	CDP - Secukinumab 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MYOCARDITIS	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CHEST PAIN	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CHILLS	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
IMPAIRED HEALING	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ERYSIPELAS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
MASTOIDITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
PYODERMA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
SINUSITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
TONSILLITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
VARICELLA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
CHEST INJURY	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RADIAL HEAD DISLOCATION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
MYCOSIS FUNGOIDES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
INTERCOSTAL NEURALGIA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
MANIA	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FIBRILLARY GLOMERULONEPHRITIS	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RENAL CYST HAEMORRHAGE	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
URETEROLITHIASIS	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ASTHMA EXERCISE INDUCED	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ACROKERATOSIS PARANEOPLASTICA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DERMATITIS EXFOLIATIVE	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HAEMORRHAGE	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONGENITAL NAEVUS	Congenital, familial and genetic disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
EAR PAIN	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
EAR PRURITUS	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPOACUSIS	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
SUDDEN HEARING LOSS	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TINNITUS	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TYMPANIC MEMBRANE PERFORATION	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
THYROID CYST	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BLEPHARITIS	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CATARACT	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CHALAZION	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONJUNCTIVAL HYPERAEMIA	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONJUNCTIVITIS ALLERGIC	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
DRY EYE	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
ECZEMA EYELIDS	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
EYE IRRITATION	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
EYE PAIN	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
EYE SWELLING	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
EYELID OEDEMA	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
EYELIDS PRURITUS	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INTRAOCULAR HAEMATOMA	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
KERATITIS	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
VISUAL IMPAIRMENT	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG00017 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
ANAL SKIN TAGS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ANORECTAL DISCOMFORT	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
COLITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
COLITIS MICROSCOPIC	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG00034 affected772 at risk EG0013 affected162 at risk EG0021 affected163 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
EPULIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FAECES SOFT	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FREQUENT BOWEL MOVEMENTS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
GASTROINTESTINAL PAIN	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0006 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
GINGIVAL DISORDER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GINGIVAL EROSION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPOAESTHESIA ORAL	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INTRA-ABDOMINAL HAEMATOMA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LIP BLISTER	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
LIP DRY	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MOUTH SWELLING	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
PARAESTHESIA ORAL	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
POUCHITIS	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TONGUE COATED	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TONGUE DISCOLOURATION	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
VASCULITIS GASTROINTESTINAL	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
VOMITING	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
APPLICATION SITE HAEMATOMA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ASTHENIA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CHILLS	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DRUG THERAPEUTIC INCOMPATIBILITY	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
FATIGUE	General disorders	MedDRA (19.1)	Systematic Assessment	EG00028 affected772 at risk EG0014 affected162 at risk EG0023 affected163 at risk
FEELING HOT	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
IMPAIRED HEALING	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA (19.1)	Systematic Assessment	EG00010 affected772 at risk EG0012 affected162 at risk EG0021 affected163 at risk
INJECTION SITE BRUISING	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INJECTION SITE ERYTHEMA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INJECTION SITE HAEMATOMA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INJECTION SITE HAEMORRHAGE	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
INJECTION SITE PAIN	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
INJECTION SITE PRURITUS	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INJURY ASSOCIATED WITH DEVICE	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PERIPHERAL SWELLING	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
PUNCTURE SITE REACTION	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PYREXIA	General disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SENSATION OF FOREIGN BODY	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
THIRST	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
SEASONAL ALLERGY	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ANGULAR CHEILITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BACTERIAL RHINITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
BACTERIAL VAGINOSIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
BALANITIS CANDIDA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BODY TINEA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BRONCHITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00010 affected772 at risk EG0012 affected162 at risk EG0022 affected163 at risk
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
CANDIDA INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONJUNCTIVITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0011 affected162 at risk EG0022 affected163 at risk
CONJUNCTIVITIS BACTERIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CYSTITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0012 affected162 at risk EG0021 affected163 at risk
CYSTITIS BACTERIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
ECZEMA IMPETIGINOUS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
EPIDIDYMITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
EPIGLOTTITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ERYSIPELAS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
FOLLICULITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00013 affected772 at risk EG0014 affected162 at risk EG0022 affected163 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FUNGAL SKIN INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FURUNCLE	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0007 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
GASTROINTESTINAL VIRAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
GENITAL CANDIDIASIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GENITAL INFECTION FUNGAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GINGIVITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
HELICOBACTER INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HERPES VIRUS INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HERPES ZOSTER	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
HERPES ZOSTER INFECTION NEUROLOGICAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
HORDEOLUM	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
IMPETIGO	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INFLUENZA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0009 affected772 at risk EG0012 affected162 at risk EG0022 affected163 at risk
LABYRINTHITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LARYNGITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
LYME DISEASE	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MUCOSAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NAIL BED INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG000168 affected772 at risk EG00123 affected162 at risk EG00227 affected163 at risk
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00014 affected772 at risk EG0012 affected162 at risk EG0023 affected163 at risk
ORAL FUNGAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ORAL HERPES	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00015 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
ORCHITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
OTITIS MEDIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
OTITIS MEDIA ACUTE	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
PARONYCHIA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
PERICHONDRITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PERIODONTITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
PHARYNGITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 affected772 at risk EG0012 affected162 at risk EG0021 affected163 at risk
PHARYNGITIS BACTERIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PULPITIS DENTAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RHINITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00016 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
SINUSITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0012 affected162 at risk EG0021 affected163 at risk
SKIN CANDIDA	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
SKIN INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
STAPHYLOCOCCAL SKIN INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
TINEA INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TINEA PEDIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0013 affected162 at risk EG0021 affected163 at risk
TONSILLITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 affected772 at risk EG0011 affected162 at risk EG0022 affected163 at risk
TONSILLITIS BACTERIAL	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
TOOTH INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
URETHRITIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
VULVOVAGINAL CANDIDIASIS	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
VULVOVAGINAL MYCOTIC INFECTION	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ACCIDENT AT WORK	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ARTHROPOD STING	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BURN ORAL CAVITY	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
CRANIOCEREBRAL INJURY	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
FOREIGN BODY IN EYE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LIGAMENT SPRAIN	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0006 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MENISCUS INJURY	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PLAQUE SHIFT	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
PROCEDURAL DIZZINESS	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SUBCUTANEOUS HAEMATOMA	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SUNBURN	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TOOTH FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BILIRUBIN URINE PRESENT	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BLOOD CHOLESTEROL INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
BLOOD TRIGLYCERIDES INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BLOOD URINE PRESENT	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BODY TEMPERATURE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ELECTROCARDIOGRAM ABNORMAL	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
ELECTROCARDIOGRAM Q WAVE ABNORMAL	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HIGH DENSITY LIPOPROTEIN DECREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
HUMAN CHORIONIC GONADOTROPIN INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MONOCYTE COUNT INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
WEIGHT INCREASED	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
FLUID RETENTION	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
GOUT	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HAEMOSIDEROSIS	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
IRON DEFICIENCY	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ZINC DEFICIENCY	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00021 affected772 at risk EG0014 affected162 at risk EG0023 affected163 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected772 at risk EG0013 affected162 at risk EG0023 affected163 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FIBROMYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
JOINT CREPITATION	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
METATARSALGIA	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MUSCLE TIGHTNESS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0022 affected163 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00012 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PATELLOFEMORAL PAIN SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PSORIATIC ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RHEUMATIC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SCOLIOSIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SYNOVIAL CYST	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
TENOSYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSPLASTIC NAEVUS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
FIBROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FIBROUS HISTIOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MELANOCYTIC NAEVUS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MONOCLONAL GAMMOPATHY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
SEBORRHOEIC KERATOSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SKIN PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0009 affected772 at risk EG0013 affected162 at risk EG0021 affected163 at risk
BURNING SENSATION	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
CERVICOGENIC VERTIGO	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
DIZZINESS	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
DYSAESTHESIA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSGEUSIA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
HEADACHE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00060 affected772 at risk EG0015 affected162 at risk EG0025 affected163 at risk
HYPERAESTHESIA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MIGRAINE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
NERVE COMPRESSION	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
NEURALGIA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NEURITIS	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ORTHOSTATIC INTOLERANCE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
SCIATICA	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0011 affected162 at risk EG0024 affected163 at risk
SOMNOLENCE	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DEPRESSION	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INITIAL INSOMNIA	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INSOMNIA	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MOOD SWINGS	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NERVOUSNESS	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
LEUKOCYTURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BALANOPOSTHITIS	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BREAST CYST	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSMENORRHOEA	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MENOPAUSAL SYMPTOMS	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MENSTRUATION IRREGULAR	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PROSTATITIS	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
PRURITUS GENITAL	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00012 affected772 at risk EG0010 affected162 at risk EG0022 affected163 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
NASAL INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
NASAL MUCOSAL EROSION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
OROPHARYNGEAL DISCOMFORT	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00012 affected772 at risk EG0011 affected162 at risk EG0022 affected163 at risk
PHARYNGEAL INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00010 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
THROAT IRRITATION	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ACTINIC KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ALOPECIA AREATA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
BLISTER	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
BLOOD BLISTER	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DERMAL CYST	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
DYSHIDROTIC ECZEMA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0012 affected162 at risk EG0022 affected163 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00010 affected772 at risk EG0014 affected162 at risk EG0021 affected163 at risk
ECZEMA WEEPING	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
ERYTHEMA NODOSUM	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INGROWING NAIL	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
INTERTRIGO	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
MILIARIA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
MYXOID CYST	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
PAIN OF SKIN	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PAPULE	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PHOTODERMATOSIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PHOTOSENSITIVITY REACTION	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PRURIGO	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00032 affected772 at risk EG0012 affected162 at risk EG0020 affected163 at risk
PRURITUS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
PRURITUS GENERALISED	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected772 at risk EG0012 affected162 at risk EG0022 affected163 at risk
PUSTULAR PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
ROSACEA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SEBORRHOEA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SEBORRHOEIC DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00013 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
SKIN ATROPHY	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SKIN FISSURES	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
SKIN IRRITATION	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0021 affected163 at risk
SKIN PLAQUE	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SKIN ULCER HAEMORRHAGE	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
SOLAR DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0007 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
DIASTOLIC HYPERTENSION	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
FLUSHING	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HAEMATOMA	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0011 affected162 at risk EG0021 affected163 at risk
HAEMORRHAGE	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected772 at risk EG0010 affected162 at risk EG0020 affected163 at risk
HYPERTENSION	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0008 affected772 at risk EG0013 affected162 at risk EG0024 affected163 at risk
LYMPHOEDEMA	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
PERIPHERAL VENOUS DISEASE	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk
VARICOSE VEIN	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected772 at risk EG0011 affected162 at risk EG0020 affected163 at risk

ID	Term
D012871	Skin Diseases
D058225	Plaque, Amyloid
D011537	Pruritus

ID	Term
D017437	Skin and Connective Tissue Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D012877	Skin Manifestations
D012816	Signs and Symptoms

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SP-Secukinumab: AIN457 300 mg s.c. (4-weekly)	In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.	32	772	510	772
EG001	CDP-Secukinumab: AIN457 300 mg s.c. (4-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).	8	162	85	162
EG002	CDP-Secukinumab: AIN457 300 mg s.c. (2-weekly)	In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)	4	163	87	163