Double-blind Extension of HORIZON Pivotal Fracture Trial... | NCT00145327

Label	Type	Description	Intervention Names
Zoledronic Acid 6	Experimental	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.	Drug: Zoledronic Acid
Zoledronic Acid 3 Placebo 3	Placebo Comparator	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.	Drug: Placebo
Placebo 3 Zoledronic Acid 3	Experimental	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.	Drug: Zoledronic Acid

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic Acid	Drug	Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.	Placebo 3 Zoledronic Acid 3 Zoledronic Acid 6

Measure	Description	Time Frame
Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3	The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).	Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)

Measure	Description	Time Frame
Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP	The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.	Year 4.5
Bone Resorption and Formation Biochemical Markers at Year 6: P1NP

Name	Affiliation	Role
Novartis Pharmaceuticals	Sponsor GmbH	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Southern Arizona VA		Tucson	Arizona	85723	United States
University of Arkansas for Medical Science

PubMed Identifier	Type	Citation	Retractions
25214069	Derived	Eastell R, Boonen S, Cosman F, Reid IR, Palermo L, Cummings SR, Black DM. Relationship between pretreatment rate of bone loss and bone density response to once-yearly ZOL: HORIZON-PFT extension study. J Bone Miner Res. 2015 Mar;30(3):570-4. doi: 10.1002/jbmr.2361.
22161728	Derived	Black DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, Cummings SR, Hue TF, Lippuner K, Lakatos P, Leung PC, Man Z, Martinez RL, Tan M, Ruzycky ME, Su G, Eastell R. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012 Feb;27(2):243-54. doi: 10.1002/jbmr.1494.

ID	Title	Description
FG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
FG001

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 Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3

The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).

Modified intent-to-treat (MITT) population. The MITT population included all patients in the ITT population who had DXA measurements of the femoral neck at Year 3 and Year 6. This was the primary population for primary efficacy parameter.

Posted

Mean

Standard Error

Percentage Change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Units	Counts
Participants	OG000451 OG001470 OG002507

Title

Denominators

Categories

Title	Measurements
	OG0000.557± 0.2154(0.43 to 1.65) OG001-0.493± 0.2249(NA to NA) OG0023.337± 0.2329

Secondary

Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP

The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.

Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The number of patients analyzed = the number of patients with measurements at Year 4.5 as determined by the analysis window.

Posted

Mean

Standard Error

ng/mL

Year 4.5

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

Bone Resorption and Formation Biochemical Markers at Year 6: P1NP

The amount of serum P1NP as determined by the central laboratory

Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. The Number of patients analyzed = the number of patients with measurements in Year 6 as determined by the analysis window.

Posted

Mean

Standard Error

ng/mL

Year 6

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3

The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).

Posted

Mean

Standard Error

Percentage Change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3

Secondary

Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3

The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).

Posted

Mean

Standard Error

Percentage change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3

Secondary

Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3

The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).

Posted

Mean

Standard Error

Percentage change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3

Secondary

Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3

The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).

Posted

Mean

Standard Error

Percentage change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3

Secondary

Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3

The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).

Posted

Mean

Standard Error

Percentage change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3

Secondary

Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3

The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).

Posted

Mean

Standard Error

Percentage change in BMD

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3

Secondary

Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures

Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.

Posted

Number

Percentage of patients

Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.

Secondary

Number of Participants With Incidence of Clinical Fracture

Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.

Intention to treat (ITT) population included all patients who were randomized or enrolled in the extension study at Visit 8. n = the number of patients with measurements at Year 6 as determined by the analysis window.

Posted

Number

Participants

Extension Baseline (Year 3; Month 36) to Year 6

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

Qualitative Bone Biopsy Parameters

Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).

Bone Biopsy sub-population.

Posted

Number

Participants

End of Study Visit at Year 6

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion

Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.

Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.

Posted

Mean

Standard Deviation

μmol/L

Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion

Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.

Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.

Posted

Mean

Standard Deviation

μmol/L

Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion

Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.

Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.

Posted

Mean

Standard Deviation

μmol/L

Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Secondary

The Number of Participants With Clinically Significant Laboratory Parameters

Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.

Safety Population included all patients in the ITT population who received at least one dose of study drug during the extension study.

Posted

Number

Participants

Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6

ID	Title	Description
OG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
OG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
OG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0011 affected616 at risk EG0025 affected1,221 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0024 affected1,221 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0011 affected616 at risk EG0026 affected1,221 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0021 affected1,221 at risk
Aortic valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG00012 affected613 at risk EG0017 affected616 at risk EG00210 affected1,221 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Atrioventricular block	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0024 affected1,221 at risk
Bundle branch block left	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0012 affected616 at risk EG0022 affected1,221 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0011 affected616 at risk EG0029 affected1,221 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0012 affected616 at risk EG0025 affected1,221 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0012 affected616 at risk EG0024 affected1,221 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 affected613 at risk EG0014 affected616 at risk EG0025 affected1,221 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pericarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0023 affected1,221 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Ototoxicity	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0013 affected616 at risk EG0020 affected1,221 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Thyrotoxic crisis	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Amaurosis fugax	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0016 affected616 at risk EG00213 affected1,221 at risk
Eye disorder	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Eye inflammation	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Eye pain	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Hyalosis asteroid	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Retinal artery embolism	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Sympathetic ophthalmia	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Trichiasis	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Uveitis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0011 affected616 at risk EG0028 affected1,221 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Anal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0025 affected1,221 at risk
Colonic stenosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0024 affected1,221 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0023 affected1,221 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Femoral hernia, obstructive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Gastrooesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0012 affected616 at risk EG0021 affected1,221 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0013 affected616 at risk EG0022 affected1,221 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Proctalgia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Subileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0011 affected616 at risk EG0023 affected1,221 at risk
Accidental death	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0023 affected1,221 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0023 affected1,221 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0023 affected1,221 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Gait disturbance	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Necrosis	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0025 affected1,221 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0013 affected616 at risk EG0021 affected1,221 at risk
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0013 affected616 at risk EG0022 affected1,221 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0016 affected616 at risk EG0023 affected1,221 at risk
Cholestasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Abdominal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Acute sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Appendicitis perforated	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0015 affected616 at risk EG0021 affected1,221 at risk
Bronchitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0012 affected616 at risk EG0021 affected1,221 at risk
Clostridial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Diarrhoea infectious	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0025 affected1,221 at risk
Endocarditis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Endometritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Endophthalmitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Furuncle	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Intervertebral discitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Labyrinthitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Laryngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Otitis externa	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected613 at risk EG0015 affected616 at risk EG00213 affected1,221 at risk
Pneumonia influenzal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Post procedural pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Tinea cruris	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Tracheitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0012 affected616 at risk EG0023 affected1,221 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0012 affected616 at risk EG0022 affected1,221 at risk
Device breakage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0014 affected616 at risk EG0027 affected1,221 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0012 affected616 at risk EG0025 affected1,221 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Fractured ischium	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0012 affected616 at risk EG0022 affected1,221 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected613 at risk EG0017 affected616 at risk EG0025 affected1,221 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0013 affected616 at risk EG0025 affected1,221 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0012 affected616 at risk EG0022 affected1,221 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected613 at risk EG0015 affected616 at risk EG0022 affected1,221 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0025 affected1,221 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0011 affected616 at risk EG0024 affected1,221 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0014 affected616 at risk EG0024 affected1,221 at risk
Barium enema	Investigations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Blood glucose decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Blood osmolarity decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Blood pressure increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0023 affected1,221 at risk
International normalised ratio decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Intraocular pressure increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0012 affected616 at risk EG0024 affected1,221 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Lipomatosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0013 affected616 at risk EG0028 affected1,221 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0023 affected1,221 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 affected613 at risk EG0014 affected616 at risk EG0023 affected1,221 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Fracture delayed union	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected613 at risk EG0014 affected616 at risk EG00213 affected1,221 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0021 affected1,221 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
B-cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0014 affected616 at risk EG0021 affected1,221 at risk
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0007 affected613 at risk EG0012 affected616 at risk EG0026 affected1,221 at risk
Carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0014 affected616 at risk EG0023 affected1,221 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0012 affected616 at risk EG0021 affected1,221 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Metastases to chest wall	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Morton's neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Mucoepidermoid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Myeloproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Nasal cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Rectal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Spinal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Urinary bladder adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Amnesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Anoxic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Aphasia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Brain injury	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Cerebral artery occlusion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0024 affected1,221 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Cerebrosclerosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected613 at risk EG0013 affected616 at risk EG0028 affected1,221 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Diabetic coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Encephalitis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Encephalomyelitis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Hemiplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Hydrocephalus	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Lacunar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Memory impairment	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Monoparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Nerve compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Nerve root compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Neurodegenerative disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Parkinson's disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Parkinsonism	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Progressive bulbar palsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Spinal claudication	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0025 affected1,221 at risk
Temporal lobe epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Thalamic infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 affected613 at risk EG0012 affected616 at risk EG0023 affected1,221 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Vascular dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Anxiety disorder due to a general medical condition	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Delirium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Mental disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Glomerulonephritis chronic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Renal cyst	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Bartholin's cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Breast fibrosis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Breast mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Cystocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Rectocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Urogenital prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0021 affected1,221 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0012 affected616 at risk EG0022 affected1,221 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected613 at risk EG0015 affected616 at risk EG0023 affected1,221 at risk
Diaphragmatic hernia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Mediastinal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Pulmonary artery stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0013 affected616 at risk EG0025 affected1,221 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0012 affected616 at risk EG0020 affected1,221 at risk
Acrodermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Immobile	Social circumstances	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Social problem	Social circumstances	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Arterial disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Arterial stenosis limb	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0023 affected1,221 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Femoral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0022 affected1,221 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0011 affected616 at risk EG0024 affected1,221 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0012 affected616 at risk EG0023 affected1,221 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0025 affected1,221 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected613 at risk EG0010 affected616 at risk EG0020 affected1,221 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0020 affected1,221 at risk
Shock	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Thrombophlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0022 affected1,221 at risk
Varicose vein	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Vasculitis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Vasoconstriction	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk
Venous insufficiency	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0011 affected616 at risk EG0021 affected1,221 at risk
Venous thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected613 at risk EG0010 affected616 at risk EG0021 affected1,221 at risk

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
BG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
BG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Zoledronic Acid 6	Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.	191	613	421	613
EG001	Zoledronic Acid 3 Placebo 3	Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.	168	616	427	616
EG002	Placebo 3 Zoledronic Acid 3	Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.	297	1,221	908	1,221