A Study of Ocrelizumab Compared to Placebo in Patients Wi... | NCT00476996

ID	Type	Description	Link
WA20495	Other Identifier	Genentech
2006-005330-20	EudraCT Number

Name	Class
Roche Pharma AG	INDUSTRY

Label	Type	Description	Intervention Names
Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy	Experimental	Participants will receive 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Drug: Leflunomide Drug: Methotrexate Drug: Ocrelizumab
Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy	Experimental	Participants will receive 2 IV infusions of 500 mg of ocrelizumab, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Drug: Leflunomide Drug: Methotrexate Drug: Ocrelizumab
Placebo x 2 IV + Non-Biologic DMARD Therapy	Placebo Comparator	Participants will receive ocrelizumab matching placebo IV in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	Drug: Leflunomide Drug: Methotrexate Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Leflunomide	Drug	Oral repeating dose	Ocrelizumab 200 mg x 2 IV + Non-Biologic DMARD Therapy Ocrelizumab 500 mg x 2 IV + Non-Biologic DMARD Therapy Placebo x 2 IV + Non-Biologic DMARD Therapy

Measure	Description	Time Frame
Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses	ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.	Weeks 24 and 48

Measure	Description	Time Frame
Percentage of Participants With a Major Clinical Response	Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.	Week 48
Percentage of Participants Achieving Disease Activity Score (DAS28) Remission

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pinnacle Research Group; Llc, Central		Anniston	Alabama	36207	United States
Rheumatology Associates

PubMed Identifier	Type	Citation	Retractions
24498318	Derived	Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
22389919	Derived	Tak PP, Mease PJ, Genovese MC, Kremer J, Haraoui B, Tanaka Y, Bingham CO 3rd, Ashrafzadeh A, Travers H, Safa-Leathers S, Kumar S, Dummer W. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012 Feb;64(2):360-70. doi: 10.1002/art.33353.

ID	Title	Description
FG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
FG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD

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

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Classes

Analyses

Primary

Percentage of Participants With American College of Rheumatology 20 (ACR20) Responses

ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.

Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.

Posted

Number

95% Confidence Interval

Percentage

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Units	Counts
Participants	OG000277 OG001277 OG002282

Title

Denominators

Categories

Percentage of Responders at Week 24

Title	Measurements
	OG00022(17.1 to 26.9) OG00142.2(36.4 to 48.1) OG00247.9(42.0 to 53.7)

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	At Week 24, analysis was stratified by region and baseline DMARD therapy	Cochran-Mantel-Haenszel		< 0.0001		Weighted Difference	20.4			2-Sided	95	12.8	27.9					Superiority
OG000 OG002	At Week 24, analysis was stratified by region and baseline DMARD therapy

Secondary

Percentage of Participants With a Major Clinical Response

Major clinical response was defined as achieving an ACR70 response and maintaining this response for a consecutive period of at least 6 months.

Posted

Number

95% Confidence Interval

Percentage

Week 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Secondary

Percentage of Participants Achieving Disease Activity Score (DAS28) Remission

The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.

Posted

Number

95% Confidence Interval

Percentage

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD

Secondary

Change in DAS28 From Baseline

Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis Number of participants for whom data were collected is indicated for each time point.

Posted

Mean

Standard Deviation

Score on a scale

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD

Secondary

Percentage of Participants With EULAR Response Rates of Good/ Moderate

The EULAR response rate was based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none.

Posted

Number

Percentage

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD

Secondary

Percentage of Participants Achieving an ACR50 Response

ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, Health Assessment Questionnaire with Disability Index (HAQ-DI), and C-Reactive Protein (CRP).

Posted

Number

95% Confidence Interval

Percentage

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002

Secondary

Percentage of Participants Achieving an ACR70 Response

ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: physician's global assessment of disease activity (MDG), patient's global assessment of disease activity (PGA), patient's assessment of pain, HAQ-DI and CRP.

Posted

Number

95% Confidence Interval

Percentage

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD

Secondary

Percentage of Participants With a Reduction in the HAQ-DI Score

Health Assessment Questionnaire - Disability Index (HAQ-DI): The Stanford Health Assessment Questionnaire disability index is a patient reported questionnaire specific for RA. It consists of 20 questions referring to eight component. Reduction in the HAQ-DI score of 0.25 units from baseline to weeks 24 and 48 represented a minimal clinically relevant improvement.

Posted

Number

95% Confidence Interval

Percentage

Weeks 24 and 48

ID	Title	Description
OG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
OG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG0031 affected664 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Granulocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0021 affected284 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0012 affected276 at risk EG0021 affected284 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0021 affected284 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0012 affected276 at risk EG0021 affected284 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Cataract	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Uveitis	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Glaucoma	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Basedow's disease	Endocrine disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0021 affected284 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Device dislocation	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Lead dislodgement	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Multi-organ failure	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Pyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Sudden death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Surgical failure	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0022 affected284 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Appendicitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Bronchitis pneumococcal	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Candida infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Bursitis infective	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Escherichia pyelonephritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Extradural abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Enterocolitis viral	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0021 affected284 at risk EG003
Genitourinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Hepatitis B	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Implant site infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Incision site cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Infectious colitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Kidney infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Parotitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Peritonitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pilonidal cyst	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Paronychia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0005 affected276 at risk EG0015 affected276 at risk EG0021 affected284 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0022 affected284 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pneumonia streptococcal	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0021 affected284 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0012 affected276 at risk EG0020 affected284 at risk EG003
Sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Septic shock	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0021 affected284 at risk EG003
Streptococcal infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Sycosis barbae	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Serratia infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Urethritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Urosepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0002 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected276 at risk EG0012 affected276 at risk EG0021 affected284 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Osteochondroitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0007 affected276 at risk EG0014 affected276 at risk EG0024 affected284 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Wrist deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Radiculitis lumbosacral	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Dementia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Somnolence	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
VIIth nerve paralysis	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Bipolar I disorder	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Pleura effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0021 affected284 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected275 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Physical assault	Social circumstances	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Hernia repair	Surgical and medical procedures	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Arteritis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0022 affected284 at risk EG003
Hypotension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected276 at risk EG0011 affected276 at risk EG0020 affected284 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Vasculitis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected276 at risk EG0010 affected276 at risk EG0020 affected284 at risk EG003

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
D007555	Isoxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
BG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
BG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo x 2 IV + Non-Biologic DMARD	Participants received Ocrelizumab matching placebo intravenously (IV) in two infusions, separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	5	276	41	276	152	276
EG001	Ocrelizumab 200 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 200 milligram (mg) of ocrelizumab (total 400 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	2	276	46	276	153	276
EG002	Ocrelizumab 500 mg x 2 + Non-Biologic DMARD	Participants received 2 intravenous (IV) infusions of 500 milligram (mg) of ocrelizumab (total 1000 mg), separated by 14 days (Day 1 and Day 15) in combination with any non-biologic DMARD	4	284	40	284	158	284
EG003	Ocrelizumab 500 mg x 2 IV + Non-biologic DMARD (OLE)	At the discretion of the investigator, eligible participants received 500 mg Ocrelizumab IV in two infusions separated by 14 days	11	664	138	664	361	664

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Darrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00010 affected276 at risk EG00115 affected276 at risk EG00215 affected284 at risk EG0030 affected664 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00015 affected276 at risk EG00111 affected276 at risk EG00210 affected284 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00019 affected276 at risk EG00128 affected276 at risk EG00222 affected284 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0009 affected276 at risk EG0017 affected276 at risk EG00215 affected284 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00031 affected276 at risk EG00128 affected276 at risk EG00222 affected284 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00014 affected276 at risk EG00113 affected276 at risk EG00213 affected284 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00036 affected276 at risk EG00137 affected276 at risk EG00245 affected284 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00023 affected276 at risk EG00119 affected276 at risk EG00224 affected284 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG00025 affected276 at risk EG00141 affected276 at risk EG00241 affected284 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG00015 affected276 at risk EG00112 affected276 at risk EG00215 affected284 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG00012 affected276 at risk EG0019 affected276 at risk EG00216 affected284 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG00021 affected276 at risk EG00118 affected276 at risk EG00219 affected284 at risk EG003