Study to Determine the Efficacy and Safety of Romosozumab... | NCT01631214

NCT01631214

ID	Type	Description	Link
2011-003142-41	EudraCT Number

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alendronate/Alendronate	Active Comparator	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.	Drug: Alendronate Drug: Placebo to Romosozumab
Romosozumab/Alendronate	Experimental	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.	Biological: Romosozumab Drug: Alendronate Drug: Placebo to Alendronate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Romosozumab	Biological	Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.	Romosozumab/Alendronate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With New Vertebral Fractures Through Month 24	All fracture assessments were performed by blinded central imaging readers. New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: Grade 0 (Normal) = no fracture; Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.	24 months
Percentage of Participants With a Clinical Fracture at the Primary Analysis	All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis	A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.	The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35294	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28892457	Background	Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
32445228	Background	Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 14, 2016	Nov 20, 2018

Arm/Group Information

ID	Title	Description
BG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
BG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00074.2± 7.5 BG00174.4± 7.5 BG00274.3± 7.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002047 BG0012046 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000662 BG001631 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0007 BG0015 BG002

Age Strata per Randomization

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 75 years	BG000976 BG001973 BG002

Severe Vertebral Fracture

A participant had a prevalent vertebral fracture if any vertebra from T4 to L4 had a grade of 3 at baseline based on an assessment of spinal radiographs using the Genant Semiquantitative Scoring Method. A grade 3 fracture is defined as approximately 40% or greater reduction in anterior, middle, and/or posterior height.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Presence	BG0001321 BG001

Total Hip Bone Mineral Density (BMD) T-score

BMD was measured using dual-energy x-ray absorptiometry (DXA). The T-score is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex. Lower scores (more negative) mean lower bone density: A T-score of -2.5 or lower qualifies as osteoporosis and a T-score of -1.0 to - 2.5 signifies osteopenia, meaning below-normal bone density without full osteoporosis.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
≤ -2.5	BG0001384 BG001

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

Percentage of Participants With New Vertebral Fractures Through Month 24

All fracture assessments were performed by blinded central imaging readers.

New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:

Grade 0 (Normal) = no fracture;
Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.

Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.

Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts
Participants	OG0001834 OG0011825

Title

Denominators

Categories

Title	Measurements
	OG0008.0 OG0014.1

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		Regression, Logistic	Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.	<0.001		Odds Ratio (OR)	0.48	Standard Error of the Mean	0.15	2-Sided	95	0.36	0.64			Values < 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).		Superiority	The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.

Primary

Percentage of Participants With a Clinical Fracture at the Primary Analysis

All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.

All randomized participants. Missing values for clinical fractures were imputed using last observation carried forward.

Posted

Number

percentage of participants

The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis

A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

All randomized participants

Posted

Number

percentage of participants

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With Any Fracture at the Primary Analysis

All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.

All randomized participants

Posted

Number

percentage of participants

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24

Grade 0 (Normal) = no fracture;
Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.

Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate

Secondary

Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis

Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.

All randomized participants

Posted

Number

percentage of participants

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With a Hip Fracture at the Primary Analysis

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

All randomized participants

Posted

Number

percentage of participants

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units

Secondary

Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24

A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With a Clinical Fracture Through Month 24

Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.

All randomized participants; Missing values for clinical fractures were imputed using last observation carried forward.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With a Nonvertebral Fracture Through Month 24

All randomized participants

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts

Secondary

Percentage of Participants With a Hip Fracture Through Month 24

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

All randomized participants

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts
Participants

Secondary

Percentage of Participants With a Clinical Vertebral Fracture Through Month 24

A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.

All randomized participants; Last observation carried forward imputation was used.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts

Secondary

Percentage of Participants With a Clinical Fracture Through Month 12

All randomized participants; Missing values for clinical fractures were imputed using last observation carried forward.

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With New Vertebral Fractures Through Month 12

Grade 0 (Normal) = no fracture;
Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.

Incident vertebral fractures were confirmed by a second independent reader.

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate

Secondary

Percentage of Participants With Any Fracture Through Month 12

All randomized participants

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts
Participants

Secondary

Percentage of Participants With a Nonvertebral Fracture Through Month 12

A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

All randomized participants

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percentage of Participants With a Hip Fracture Through Month 12

Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.

All randomized participants

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts
Participants

Secondary

Percentage of Participants With a Major Osteoporotic Fracture Through Month 12

Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.

All randomized participants

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts
Participants

Secondary

Percentage of Participants With a Clinical Vertebral Fracture Through Month 12

All randomized participants; Last observation carried forward imputation was used.

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts

Secondary

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 24

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 24

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 24

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

All randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 12

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts

Secondary

Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

All randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 12

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts

Secondary

Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

All randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 12

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Units	Counts

Secondary

Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 36

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 36

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Secondary

Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36

Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and month 36

ID	Title	Description
OG000	Alendronate/Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
OG001	Romosozumab/Alendronate	Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-blind Period: Alendronate 70 mg QW	Participants received 70 mg alendronate once a week (QW) and placebo to romosozumab subcutaneously once a month for 12 months during the double-blind treatment period.	22	2,014	278	2,014	1,190	2,014
EG001	Double-blind Period: Romosozumab 210 mg QM	Participants received 210 mg romosozumab subcutaneously once a month (QM) and placebo to alendronate orally once a week for the first 12 months during the double-blind treatment period.	30	2,040	262	2,040	1,112	2,040
EG002	Overall Study: Alendronate / Alendronate	Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.	103	2,014	638	2,014	1,498	2,014
EG003	Overall Study: Romosozumab / Alendronate	Participants received 210 romosozumab mg subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.	101	2,040	611	2,040	1,424	2,040

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0011 affected2,040 at risk EG0029 affected2,014 at risk EG0037 affected2,040 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0018 affected2,040 at risk EG00215 affected2,014 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0012 affected2,040 at risk EG0026 affected2,014 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0012 affected2,040 at risk EG0027 affected2,014 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Arteriospasm coronary	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0013 affected2,040 at risk EG00217 affected2,014 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0010 affected2,040 at risk EG0024 affected2,014 at risk EG003
Bradyarrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected2,014 at risk EG0015 affected2,040 at risk EG00225 affected2,014 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0025 affected2,014 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected2,014 at risk EG0012 affected2,040 at risk EG00212 affected2,014 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0025 affected2,014 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Myocardial fibrosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0015 affected2,040 at risk EG0028 affected2,014 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0013 affected2,040 at risk EG0024 affected2,014 at risk EG003
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0025 affected2,014 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Vestibular ataxia	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Basedow's disease	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Goitre	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0024 affected2,014 at risk EG003
Hypercorticoidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Toxic goitre	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Amaurosis	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0013 affected2,040 at risk EG0029 affected2,014 at risk EG003
Diplopia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Endocrine ophthalmopathy	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Entropion	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Macular fibrosis	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Neovascular age-related macular degeneration	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Retinal artery thrombosis	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Strabismus	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Visual impairment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Vitreous prolapse	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0021 affected2,014 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0014 affected2,040 at risk EG0023 affected2,014 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Duodenal polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Femoral hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Femoral hernia incarcerated	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0026 affected2,014 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Intestinal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Mechanical ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Peritoneal adhesions	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Rectal prolapse	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0013 affected2,040 at risk EG0020 affected2,014 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Adverse event	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG00221 affected2,014 at risk EG003
Feeling abnormal	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Hypothermia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Impaired healing	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Strangulated hernia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Sudden death	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Ulcer haemorrhage	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Vessel puncture site haemorrhage	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ampulla of Vater stenosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Biliary cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Biliary fibrosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected2,014 at risk EG0015 affected2,040 at risk EG0029 affected2,014 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Amyloidosis	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0011 affected2,040 at risk EG0028 affected2,014 at risk EG003
Bronchitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0011 affected2,040 at risk EG0026 affected2,014 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cystitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Empyema	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Enterocolitis bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Gastritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0012 affected2,040 at risk EG0026 affected2,014 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Haematoma infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hepatitis C	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Infected bite	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Infected fistula	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Kidney infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Localised infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Nosocomial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pancreas infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Peritonitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0013 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00017 affected2,014 at risk EG00116 affected2,040 at risk EG00246 affected2,014 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0011 affected2,040 at risk EG0026 affected2,014 at risk EG003
Post procedural infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Post procedural sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pyoderma	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Rhinitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0008 affected2,014 at risk EG0018 affected2,040 at risk EG00221 affected2,014 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Urosepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0023 affected2,014 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Burns third degree	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0027 affected2,014 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0012 affected2,040 at risk EG00211 affected2,014 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00012 affected2,014 at risk EG0015 affected2,040 at risk EG00231 affected2,014 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00012 affected2,014 at risk EG00111 affected2,040 at risk EG00251 affected2,014 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0013 affected2,040 at risk EG0029 affected2,014 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0010 affected2,040 at risk EG0025 affected2,014 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Fractured ischium	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Graft complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0007 affected2,014 at risk EG0013 affected2,040 at risk EG00216 affected2,014 at risk EG003
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Lip injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0028 affected2,014 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0025 affected2,014 at risk EG003
Post laminectomy syndrome	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0010 affected2,040 at risk EG0027 affected2,014 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00012 affected2,014 at risk EG0018 affected2,040 at risk EG00220 affected2,014 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Subarachnoid haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0025 affected2,014 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0005 affected2,014 at risk EG0013 affected2,040 at risk EG0028 affected2,014 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0006 affected2,014 at risk EG0013 affected2,040 at risk EG00211 affected2,014 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Carcinoembryonic antigen increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Coagulation time prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Heart rate decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Liver function test abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Medical observation normal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0025 affected2,014 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0013 affected2,040 at risk EG0027 affected2,014 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Metabolic disorder	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected2,014 at risk EG0012 affected2,040 at risk EG00217 affected2,014 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Extraskeletal ossification	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0025 affected2,014 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0021 affected2,014 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected2,014 at risk EG0016 affected2,040 at risk EG00211 affected2,014 at risk EG003
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0013 affected2,040 at risk EG0024 affected2,014 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Bladder squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0024 affected2,014 at risk EG003
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Central nervous system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cervix carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Colorectal carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Epithelioid mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hepatobiliary cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intra-abdominal haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intraocular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Lung adenocarcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Malignant neoplasm of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Mediastinum neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Metastases to pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Non-Hodgkin's lymphoma unspecified histology indolent stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Retroperitoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Squamous cell carcinoma of pharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Squamous cell carcinoma of the vulva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Amnesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Aphasia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Carotid aneurysm rupture	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cerebral arteriosclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected2,014 at risk EG0016 affected2,040 at risk EG00215 affected2,014 at risk EG003
Cerebrovascular disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Dementia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0011 affected2,040 at risk EG0027 affected2,014 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0013 affected2,040 at risk EG0022 affected2,014 at risk EG003
Essential tremor	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Extrapyramidal disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hypokinesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hypotonia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ischaemic neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0012 affected2,040 at risk EG00210 affected2,014 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Mixed dementia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Monoparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Multiple sclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Multiple sclerosis relapse	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Nerve root compression	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Neuralgia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Optic neuritis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Paraparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Paresis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Post-traumatic epilepsy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Somnolence	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Stroke in evolution	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0012 affected2,040 at risk EG00210 affected2,014 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0016 affected2,040 at risk EG0025 affected2,014 at risk EG003
Vascular encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Device breakage	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Device dislocation	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Device failure	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Device malfunction	Product Issues	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0025 affected2,014 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hypomania	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0015 affected2,040 at risk EG0022 affected2,014 at risk EG003
Bladder prolapse	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Urethral polyp	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Colpocele	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Pelvic haematoma	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0012 affected2,040 at risk EG0022 affected2,014 at risk EG003
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0012 affected2,040 at risk EG0026 affected2,014 at risk EG003
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 affected2,014 at risk EG0015 affected2,040 at risk EG00229 affected2,014 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0024 affected2,014 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0025 affected2,014 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0012 affected2,040 at risk EG0024 affected2,014 at risk EG003
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Vocal cord cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0023 affected2,014 at risk EG003
Limb prosthesis user	Social circumstances	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Loss of personal independence in daily activities	Social circumstances	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hip arthroplasty	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hospitalisation	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Surgery	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Umbilical hernia repair	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0024 affected2,014 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Aortic arteriosclerosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0020 affected2,014 at risk EG003
Aortic dissection	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Blood pressure inadequately controlled	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected2,014 at risk EG0012 affected2,040 at risk EG0029 affected2,014 at risk EG003
Embolism arterial	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected2,014 at risk EG0011 affected2,040 at risk EG0028 affected2,014 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected2,014 at risk EG0010 affected2,040 at risk EG0025 affected2,014 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0011 affected2,040 at risk EG0021 affected2,014 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Labile hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0022 affected2,014 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0012 affected2,040 at risk EG0025 affected2,014 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0011 affected2,040 at risk EG0023 affected2,014 at risk EG003
Phlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Subclavian artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected2,014 at risk EG0010 affected2,040 at risk EG0022 affected2,014 at risk EG003
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0021 affected2,014 at risk EG003
Varicose vein	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected2,014 at risk EG0010 affected2,040 at risk EG0020 affected2,014 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG00049 affected2,014 at risk EG00141 affected2,040 at risk EG002113 affected2,014 at risk EG00384 affected2,040 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG00032 affected2,014 at risk EG00146 affected2,040 at risk EG00297 affected2,014 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00063 affected2,014 at risk EG00162 affected2,040 at risk EG002109 affected2,014 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00092 affected2,014 at risk EG00175 affected2,040 at risk EG002133 affected2,014 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00093 affected2,014 at risk EG00199 affected2,040 at risk EG002168 affected2,014 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00059 affected2,014 at risk EG00153 affected2,040 at risk EG002101 affected2,014 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG000100 affected2,014 at risk EG00188 affected2,040 at risk EG002187 affected2,014 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00057 affected2,014 at risk EG00149 affected2,040 at risk EG002119 affected2,014 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG000132 affected2,014 at risk EG001130 affected2,040 at risk EG002226 affected2,014 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG000128 affected2,014 at risk EG00197 affected2,040 at risk EG002244 affected2,014 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG000233 affected2,014 at risk EG001217 affected2,040 at risk EG002406 affected2,014 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG00071 affected2,014 at risk EG00151 affected2,040 at risk EG002161 affected2,014 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG000151 affected2,014 at risk EG001127 affected2,040 at risk EG002342 affected2,014 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG000193 affected2,014 at risk EG001165 affected2,040 at risk EG002380 affected2,014 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG000221 affected2,014 at risk EG001184 affected2,040 at risk EG002395 affected2,014 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00081 affected2,014 at risk EG00170 affected2,040 at risk EG002128 affected2,014 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00083 affected2,014 at risk EG00170 affected2,040 at risk EG002155 affected2,014 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG000111 affected2,014 at risk EG001113 affected2,040 at risk EG002206 affected2,014 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG000129 affected2,014 at risk EG001121 affected2,040 at risk EG002253 affected2,014 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00080 affected2,014 at risk EG00185 affected2,040 at risk EG002152 affected2,014 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG000110 affected2,014 at risk EG001106 affected2,040 at risk EG002190 affected2,014 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00055 affected2,014 at risk EG00174 affected2,040 at risk EG002118 affected2,014 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG000130 affected2,014 at risk EG001113 affected2,040 at risk EG002232 affected2,014 at risk EG003

ID	Term
D010024	Osteoporosis
D015663	Osteoporosis, Postmenopausal
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals