An Efficacy and Safety Study of Golimumab in Patients Wit... | NCT00264550

ID	Type	Description	Link
C0524T06	Other Identifier	Centocor
2004-003296-36	EudraCT Number

Name	Class
Schering-Plough	INDUSTRY

Description Module

Detailed Description

This is a randomized (treatment is assigned by chance), double-blind (neither the physician nor the patient is aware of the received treatment), placebo-controlled study of multiple subcutaneous (SC) administrations of golimumab at 2 doses as monotherapy or in combination with MTX in patients with active RA despite treatment with MTX. The duration of participation in the study for an individual patient will be upto 268 weeks. The patients will be randomly assigned in a 3:3:2:2 ratio to receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks through week 20 and methotrexate or placebo capsules will be given in addition. At Week 24, all subjects will receive golimumab 50mg or 100mg injections, and golimumab continues for all groups for about 4 and a half more years. At Week 16 any patient in the study who meets criteria for < 20% improvement from baseline in both swollen and tender joint count will enter early escape in a double-blinded fashion. Treatment during the long-term extension will start at Week 52 and continue every 4 weeks thereafter for a total of approximately 5 years from the initial (Week 0) administration of study agent. Patients will return for scheduled follow-up visits generally every 12 weeks for a total length of follow-up of approximately 5 years from the first administration of the study drug.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Placebo + Methotrexate	Placebo Comparator	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.	Drug: Methotrexate Drug: Placebo injection
Group 2: Golimumab 100 mg + Placebo	Experimental	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.	Drug: Golimumab 100 mg Drug: Placebo capsules
Group 3: Golimumab 50 mg + Methotrexate	Experimental	Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Golimumab 100 mg	Drug	Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.	Group 2: Golimumab 100 mg + Placebo Group 4: Golimumab 100 mg + Methotrexate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14	ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.	Week 14
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24	HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).	Baseline (Week 0) and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14	DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening
Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
Are considered eligible according to specified tuberculosis (TB) screening criteria

Exclusion Criteria:

Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent
Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab)
Have had history of, or ongoing, chronic or recurrent infectious disease.
Have serious infection within 2 months prior to first administration of study agent
Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening

Name	Affiliation	Role
Centocor, Inc. Clinical Trial	Centocor, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
30412238	Derived	Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.
28606966	Derived	George MD, Ostergaard M, Conaghan PG, Emery P, Baker DG, Baker JF. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis. Ann Rheum Dis. 2017 Oct;76(10):1743-1746. doi: 10.1136/annrheumdis-2017-211569. Epub 2017 Jun 12.

ID	Title	Description
FG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.

Arm/Group Information

ID	Title	Description
BG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
BG001	Group 2: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
BG002	Group 3: Golimumab 50 mg + Methotrexate	Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
BG003	Group 4: Golimumab 100 mg + Methotrexate	Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
BG004	Total	Total of all reporting groups

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 Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14

ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.

All participants randomly assigned to each treatment group

Posted

Number

Participants

Week 14

ID	Title	Description
OG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG001	Group 2: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG002	Group 3: Golimumab 50 mg + Methotrexate	Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG003	Group 4: Golimumab 100 mg + Methotrexate	Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG004	Combined Golimumab + Methotrexate	Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)

Units	Counts
Participants	OG000133 OG001133 OG00289 OG003

Title

Denominators

Categories

Title	Measurements
	OG00044 OG00159 OG00249 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004	Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.	Chi-squared		<0.001	The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.												No	Superiority or Other

Secondary

Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14

DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of <= 3.2 (good response) or > 3.2 to 5.1 (moderate response).

All participants randomly assigned to each treatment group

Posted

Number

Participants

Week 14

ID	Title	Description
OG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG001	Group 2: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.

Primary

Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24

HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).

All participants randomly assigned to each treatment group

Posted

Median

Inter-Quartile Range

Units on a scale

Baseline (Week 0) and Week 24

ID	Title	Description
OG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG001	Group 2: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.

Secondary

Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24

An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).

All participants randomly assigned to each treatment group

Posted

Number

Participants

Week 24

ID	Title	Description
OG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG001	Group 2: Golimumab 100 mg + Placebo

Secondary

Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14

The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).

All participants randomly assigned to each treatment group

Posted

Median

Inter-Quartile Range

Units on a scale

Baseline (Week 0) and Week 14

ID	Title	Description
OG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG001	Group 2: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.

Secondary

Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24

The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.

All participants randomly assigned to each treatment group

Posted

Median

Inter-Quartile Range

Units on a scale

Baseline (Week 0) and Week 24

ID	Title	Description
OG000	Group 1: Placebo + Methotrexate	Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
OG001	Group 2: Golimumab 100 mg + Placebo	Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0022 affected145 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Angina Unstable	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Atrioventricular Block	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Cardiovascular Insufficiency	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Cyanosis	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Dressler's Syndrome	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Deafness Neurosensory	Ear and labyrinth disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Goitre	Endocrine disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected105 at risk EG0010 affected184 at risk EG0022 affected145 at risk
Retinal Detachment	Eye disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Scleritis	Eye disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Scotoma	Eye disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0022 affected145 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Oesophagitis Ulcerative	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Parotid Gland Enlargement	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Chest Pain	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Necrosis	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Pain	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Pyrexia	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Acute Hepatic Failure	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0022 affected145 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0022 affected145 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0015 affected184 at risk EG0023 affected145 at risk
Hepatitis	Hepatobiliary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Anti-Neutrophil Cytoplasmic Antibody Positive Vasculitis	Immune system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Sarcoidosis	Immune system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Abscess Limb	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Arthritis Bacterial	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Arthritis Infective	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Bronchitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0021 affected145 at risk
Cellulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0014 affected184 at risk EG0021 affected145 at risk
Chronic Sinusitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Chronic Tonsillitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Disseminated Tuberculosis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Diverticulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Empyema	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0021 affected145 at risk
Hepatitis E	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Incision Site Cellulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Lobar Pneumonia	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Mastoiditis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Otitis Externa	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Peritoneal Tuberculosis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Pneumonia	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0002 affected105 at risk EG0013 affected184 at risk EG0022 affected145 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Sepsis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0015 affected184 at risk EG0021 affected145 at risk
Septic Arthritis Staphylococcal	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Septic Shock	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Sinusitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Tuberculous Pleurisy	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Vulval Cellulitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Abdominal Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Brain Contusion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Limb Crushing Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Postpericardiotomy Syndrome	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Spinal Column Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Tendon Injury	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Weight Decreased	Investigations	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0013 affected184 at risk EG0022 affected145 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0022 affected145 at risk
Joint Destruction	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0022 affected145 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0013 affected184 at risk EG0023 affected145 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected105 at risk EG0016 affected184 at risk EG0025 affected145 at risk
Rheumatoid Nodule	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Soft Tissue Necrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0002 affected105 at risk EG0014 affected184 at risk EG0021 affected145 at risk
Bowen's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Breast Cancer in Situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Bronchial Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Endometrial Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Lung Adenocarcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Lymphoproliferative Disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0002 affected105 at risk EG0012 affected184 at risk EG0022 affected145 at risk
Thyroid Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0023 affected145 at risk
Axonal Neuropathy	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Convulsion	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Migraine	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Paresis	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Syncope	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0021 affected145 at risk
Suicide Attempt	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Incontinence	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0021 affected145 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Stress Urinary Incontinence	Renal and urinary disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Breast Calcifications	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Breast Enlargement	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Cystocele	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Dysfunctional Uterine Bleeding	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Menopausal Symptoms	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Pelvic Adhesions	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Uterine Prolapse	Reproductive system and breast disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0021 affected145 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Nasal Septum Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Obstructive Airways Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Vocal Cord Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Vocal Cord Polyp	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG0010 affected184 at risk EG0020 affected145 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0012 affected184 at risk EG0020 affected145 at risk
Hypertensive Emergency	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0011 affected184 at risk EG0020 affected145 at risk
Venous Thrombosis	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0000 affected105 at risk EG0010 affected184 at risk EG0021 affected145 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 15.0	Systematic Assessment	EG0005 affected105 at risk EG00111 affected184 at risk EG0027 affected145 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected105 at risk EG00111 affected184 at risk EG0027 affected145 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0009 affected105 at risk EG00113 affected184 at risk EG00215 affected145 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG00016 affected105 at risk EG00124 affected184 at risk EG00211 affected145 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0007 affected105 at risk EG00111 affected184 at risk EG0024 affected145 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0007 affected105 at risk EG0019 affected184 at risk EG0025 affected145 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0005 affected105 at risk EG0016 affected184 at risk EG0028 affected145 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0009 affected105 at risk EG00123 affected184 at risk EG00211 affected145 at risk
Fatigue	General disorders	MedDRA Version 15.0	Systematic Assessment	EG00011 affected105 at risk EG0019 affected184 at risk EG0023 affected145 at risk
Injection Site Erythema	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG00120 affected184 at risk EG0023 affected145 at risk
Oedema Peripheral	General disorders	MedDRA Version 15.0	Systematic Assessment	EG0002 affected105 at risk EG00110 affected184 at risk EG0029 affected145 at risk
Bronchitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00018 affected105 at risk EG00127 affected184 at risk EG00228 affected145 at risk
Fungal Skin Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0006 affected105 at risk EG0012 affected184 at risk EG0022 affected145 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG00111 affected184 at risk EG0027 affected145 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0009 affected105 at risk EG00111 affected184 at risk EG00210 affected145 at risk
Influenza	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG00111 affected184 at risk EG0029 affected145 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00015 affected105 at risk EG00135 affected184 at risk EG00224 affected145 at risk
Oral Herpes	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG0019 affected184 at risk EG00211 affected145 at risk
Pharyngitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00013 affected105 at risk EG00120 affected184 at risk EG00225 affected145 at risk
Rhinitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0007 affected105 at risk EG0015 affected184 at risk EG0023 affected145 at risk
Sinusitis	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0006 affected105 at risk EG00120 affected184 at risk EG00216 affected145 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG00039 affected105 at risk EG00164 affected184 at risk EG00239 affected145 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 15.0	Systematic Assessment	EG0009 affected105 at risk EG00120 affected184 at risk EG00220 affected145 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 15.0	Systematic Assessment	EG0005 affected105 at risk EG00113 affected184 at risk EG0028 affected145 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 15.0	Systematic Assessment	EG0008 affected105 at risk EG00119 affected184 at risk EG00211 affected145 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 15.0	Systematic Assessment	EG0005 affected105 at risk EG00117 affected184 at risk EG0027 affected145 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA Version 15.0	Systematic Assessment	EG0007 affected105 at risk EG00114 affected184 at risk EG00210 affected145 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG00016 affected105 at risk EG00118 affected184 at risk EG00215 affected145 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG00010 affected105 at risk EG00122 affected184 at risk EG00220 affected145 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG00110 affected184 at risk EG0027 affected145 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG00110 affected184 at risk EG0024 affected145 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0004 affected105 at risk EG00110 affected184 at risk EG0026 affected145 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG00013 affected105 at risk EG00122 affected184 at risk EG00215 affected145 at risk
Headache	Nervous system disorders	MedDRA Version 15.0	Systematic Assessment	EG00013 affected105 at risk EG00122 affected184 at risk EG00220 affected145 at risk
Depression	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0001 affected105 at risk EG00110 affected184 at risk EG00210 affected145 at risk
Insomnia	Psychiatric disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected105 at risk EG00111 affected184 at risk EG0029 affected145 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG00024 affected105 at risk EG00135 affected184 at risk EG00214 affected145 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG00010 affected105 at risk EG00110 affected184 at risk EG0027 affected145 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0008 affected105 at risk EG0018 affected184 at risk EG0021 affected145 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0007 affected105 at risk EG0016 affected184 at risk EG0026 affected145 at risk
Upper Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.0	Systematic Assessment	EG0007 affected105 at risk EG0013 affected184 at risk EG0023 affected145 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0006 affected105 at risk EG0016 affected184 at risk EG0024 affected145 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0003 affected105 at risk EG00119 affected184 at risk EG00215 affected145 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 15.0	Systematic Assessment	EG0008 affected105 at risk EG0016 affected184 at risk EG0022 affected145 at risk
Hypertension	Vascular disorders	MedDRA Version 15.0	Systematic Assessment	EG0008 affected105 at risk EG00125 affected184 at risk EG00221 affected145 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: Golimumab 50 mg SC Injections Only	Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.	33	105	96	105
EG001	Group 2: Golimumab 100 mg SC Injections Only	Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.	84	184	160	184
EG002	Group 3: Golimumab 50 and 100 mg SC Injections	Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.	55	145	118	145