A Study of Ocrelizumab in Participants With Primary Progr... | NCT01194570

ID	Type	Description	Link
2010-020338-25	EudraCT Number

Label	Type	Description	Intervention Names
Placebo	Experimental	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.	Drug: Ocrelizumab Other: Placebo
Ocrelizumab 600 mg	Placebo Comparator	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.	Drug: Ocrelizumab

Name	Type	Description	Arm Group Labels	Other Names
Ocrelizumab	Drug	Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.

Measure	Description	Time Frame
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period	The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.	Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

Measure	Description	Time Frame
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period	The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Neurological Associates Ltd		Phoenix	Arizona	85006	United States
Barrow Neurology Clinic

PubMed Identifier	Type	Citation	Retractions
40258203	Derived	Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.
38071574	Derived

ID	Title	Description
FG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
FG001	Ocrelizumab 600 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 20, 2021	Dec 18, 2023

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

Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period

The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.

ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.

Posted

Median

Full Range

weeks

Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Units	Counts
Participants	OG000244 OG001487

Title

Denominators

Categories

Title	Measurements
	OG000NA(0 to NA)The median and upper limit of full range for time to onset of CDP has not been reached due to low number of participants with the event at the end of the study. OG001NA(0 to NA)The median and upper limit of full range for time to onset of CDP has not been reached due to low number of participants with the event at the end of the study.

Secondary

Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period

ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint.

Posted

Median

Full Range

weeks

Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Secondary

Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120

ITT population included all randomized participants in the study. Here, number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.

Posted

Least Squares Mean

95% Confidence Interval

percent change

Baseline, Week 120

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Volume of T2 Lesions at Week 120

ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.

Posted

Least Squares Mean

95% Confidence Interval

percent change

From Baseline to Week 120

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Brain Volume From Week 24 to Week 120

ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint. Here, least square mean is indicating adjusted mean.

Posted

Least Squares Mean

95% Confidence Interval

percent change

From Week 24 to Week 120

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.

Units	Counts
Participants	OG000

Secondary

Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120

The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0-100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

From Baseline to Week 120

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001

Secondary

Number of Participants With at Least One Adverse Event (AE)

AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.

The safety population includes all participants who received at least one dose of study drug.

Posted

Number

Participants

From baseline to 9 years

ID	Title	Description
OG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
OG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
OG002	Placebo (Open Label Extension)	During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks.
OG003	Ocrelizumab (Open Label Extension)	During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
AGRANULOCYTOSIS	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG0030 events0 affected369 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ANAEMIA MEGALOBLASTIC	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ANGINA UNSTABLE	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CARDIOMYOPATHY	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CORONARY ARTERY INSUFFICIENCY	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SINUS TACHYCARDIA	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CATARACT	Eye disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
EPIRETINAL MEMBRANE	Eye disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
EYE INFLAMMATION	Eye disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
GLAUCOMA	Eye disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
RETINAL DISORDER	Eye disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ANAL FISSURE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
ANAL POLYP	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ANORECTAL VARICES	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
COLITIS	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
DIVERTICULUM	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DUODENAL ULCER	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
FAECALOMA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
GASTRIC FISTULA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
GASTROINTESTINAL POLYP HAEMORRHAGE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ILEUS	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
INCARCERATED UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
OESOPHAGEAL RUPTURE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
VOLVULUS	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ASTHENIA	General disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CHEST PAIN	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
DRUG INTOLERANCE	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
FATIGUE	General disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
GAIT DISTURBANCE	General disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HYPERTHERMIA	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
INFLAMMATION	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
PYREXIA	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
SUDDEN CARDIAC DEATH	General disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SUDDEN DEATH	General disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
CHOLANGITIS	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HEPATITIS ACUTE	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ABSCESS LIMB	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ABSCESS OF EYELID	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ANAL ABSCESS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0022 events2 affected158 at risk EG003
APPENDICITIS PERFORATED	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BACTERIAL INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BACTERIAL PYELONEPHRITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
BORRELIA INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BRONCHIOLITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
BURSITIS INFECTIVE	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
CANDIDA SEPSIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CELLULITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events3 affected486 at risk EG0026 events2 affected158 at risk EG003
CHOLECYSTITIS INFECTIVE	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
COVID-19	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0022 events2 affected158 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0026 events5 affected158 at risk EG003
CYSTITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DENGUE FEVER	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
ENCEPHALITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
EPIDIDYMITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
GANGRENE	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0021 events1 affected158 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HEPATITIS VIRAL	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HERPES OPHTHALMIC	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
IMPETIGO	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
INFECTED DERMAL CYST	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
INFLUENZA	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
LARGE INTESTINE INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MASTITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MENINGITIS ASEPTIC	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0002 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MENINGITIS BACTERIAL	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ORCHITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
OTITIS EXTERNA	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PELVIC INFLAMMATORY DISEASE	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PERITONITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0004 events3 affected239 at risk EG0017 events6 affected486 at risk EG0024 events3 affected158 at risk EG003
PNEUMONIA ASPIRATION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0021 events1 affected158 at risk EG003
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PNEUMONIA ESCHERICHIA	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
POST PROCEDURAL SEPSIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PYELOCYSTITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PYELONEPHRITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
SEPSIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0023 events2 affected158 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
SINUSITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SUSPECTED COVID-19	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
TOOTH INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0005 events4 affected239 at risk EG0014 events4 affected486 at risk EG00210 events7 affected158 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0013 events2 affected486 at risk EG0022 events2 affected158 at risk EG003
VESTIBULAR NEURONITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
VIRAL INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
VIRAL PERICARDITIS	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
ZIKA VIRUS INFECTION	Infections and infestations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events2 affected486 at risk EG0021 events1 affected158 at risk EG003
CARDIAC CONTUSION	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0022 events1 affected158 at risk EG003
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
FRACTURE DISPLACEMENT	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
FRACTURED SACRUM	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
INCISION SITE IMPAIRED HEALING	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0015 events5 affected486 at risk EG0021 events1 affected158 at risk EG003
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
POST LUMBAR PUNCTURE SYNDROME	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
POST PROCEDURAL FEVER	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
POST PROCEDURAL HAEMATURIA	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BLOOD GLUCOSE FLUCTUATION	Investigations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HELICOBACTER TEST POSITIVE	Investigations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events4 affected486 at risk EG0020 events0 affected158 at risk EG003
CHONDROPATHY	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
POLYARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
SERONEGATIVE ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
ADENOCARCINOMA OF THE CERVIX	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ANAPLASTIC LARGE-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BENIGN PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BENIGN VAGINAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BORDERLINE SEROUS TUMOUR OF OVARY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
CHONDROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HEPATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
INTRADUCTAL PAPILLARY BREAST NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
INVASIVE BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
INVASIVE DUCTAL BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0022 events2 affected158 at risk EG003
KERATOACANTHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MALIGNANT FIBROUS HISTIOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MENINGIOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
NODULAR MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PANCREATIC CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
PARAGANGLION NEOPLASM BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ROSAI-DORFMAN SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SOFT TISSUE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected486 at risk EG0020 events0 affected158 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0022 events2 affected158 at risk EG003
EMBOLIC STROKE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
EPILEPSY	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
GENERALISED TONIC-CLONIC SEIZURE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HEADACHE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HEMIPARESIS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
INTRACRANIAL ANEURYSM	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
INTRACRANIAL PRESSURE INCREASED	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MIGRAINE WITH AURA	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
MULTIPLE SCLEROSIS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MULTIPLE SCLEROSIS PSEUDO RELAPSE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MULTIPLE SCLEROSIS RELAPSE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0014 events4 affected486 at risk EG0020 events0 affected158 at risk EG003
MUSCLE SPASTICITY	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
OPTIC NEURITIS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
PARALYSIS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PARAPARESIS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
PARKINSON'S DISEASE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
PRESYNCOPE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
SCIATICA	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
SEIZURE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
STATUS EPILEPTICUS	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events2 affected486 at risk EG0021 events1 affected158 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
TRIGEMINAL NEURALGIA	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events2 affected486 at risk EG0023 events2 affected158 at risk EG003
UHTHOFF'S PHENOMENON	Nervous system disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BEHAVIOUR DISORDER	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
COMPLETED SUICIDE	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DEPRESSION SUICIDAL	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MAJOR DEPRESSION	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0012 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
MANIA	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
SUICIDAL IDEATION	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0013 events3 affected486 at risk EG0020 events0 affected158 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BLADDER PERFORATION	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CALCULUS URINARY	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0012 events2 affected486 at risk EG0021 events1 affected158 at risk EG003
PROTEINURIA	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0011 events1 affected486 at risk EG0021 events1 affected158 at risk EG003
CERVICAL POLYP	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
ENDOMETRIAL HYPERPLASIA	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
FIBROCYSTIC BREAST DISEASE	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
INTERMENSTRUAL BLEEDING	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
OVARIAN CYST	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
OVARIAN CYST TORSION	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
UTERINE PROLAPSE	Reproductive system and breast disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0022 events1 affected158 at risk EG003
ALVEOLITIS	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HYPERSENSITIVITY PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PNEUMOTHORAX SPONTANEOUS	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PULMONARY GRANULOMA	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
PULMONARY THROMBOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
VOCAL CORD THICKENING	Respiratory, thoracic and mediastinal disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
ACTINIC KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0002 events2 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
LICHEN PLANUS	Skin and subcutaneous tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PRURITUS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
DRY GANGRENE	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0021 events1 affected158 at risk EG003
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0011 events1 affected486 at risk EG0020 events0 affected158 at risk EG003
PERIPHERAL ARTERY OCCLUSION	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0000 events0 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003
VARICOSE VEIN	Vascular disorders	MedDRA V 25.1	Systematic Assessment	EG0001 events1 affected239 at risk EG0010 events0 affected486 at risk EG0020 events0 affected158 at risk EG003

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Placebo	Participants with primary progressive multiple sclerosis (PPMS) received placebo matched to ocrelizumab at a schedule interval of 24 weeks up to at least 120 weeks.
BG001	Ocrelizumab 600 mg	Participants with PPMS received ocrelizumab as two IV infusions of 300 mg separated by 14 days at a scheduled interval of every 24 weeks up to at least 120 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DB PLACEBO	3	239	58	239	175	239
EG001	DB OCRELIZUMAB	3	486	104	486	400	486
EG002	OLE PLACEBO	4	158	59	158	134	158
EG003	OLE OCRELIZUMAB	19	369	167	369	318	369