Efficacy in Reducing Fractures and Safety of Zoledronic A... | NCT00439647

NCT00439647

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zoledronic Acid	Experimental	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.	Drug: Zoledronic acid 5 mg iv
Placebo	Placebo Comparator	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic acid 5 mg iv	Drug	Zoledronic acid 5 mg iv given once a year.	Zoledronic Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months	Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height	24 Months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months	Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Argentina	Principal Investigator
Novartis Pharmaceuticals	Novartis Belgium	Principal Investigator
Novartis Pharmaceuticals	Novartis Brazil	Principal Investigator
Novartis Pharmaceuticals	Novartis Czech Republic	Principal Investigator
Novartis Pharmaceuticals	Novartis Denmark	Principal Investigator
Novartis Pharmaceuticals	Novartis Finland	Principal Investigator
Novartis Pharmaceuticals	Novartis Germany	Principal Investigator
Novartis Pharmaceuticals	Novartis Hungary	Principal Investigator
Novartis Pharmaceuticals	Novartis Norway	Principal Investigator
Novartis Pharmaceuticals

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Buenos Aires			Argentina
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23113482	Derived	Boonen S, Reginster JY, Kaufman JM, Lippuner K, Zanchetta J, Langdahl B, Rizzoli R, Lipschitz S, Dimai HP, Witvrouw R, Eriksen E, Brixen K, Russo L, Claessens F, Papanastasiou P, Antunez O, Su G, Bucci-Rechtweg C, Hruska J, Incera E, Vanderschueren D, Orwoll E. Fracture risk and zoledronic acid therapy in men with osteoporosis. N Engl J Med. 2012 Nov 1;367(18):1714-23. doi: 10.1056/NEJMoa1204061.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
BG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001.6 OG0014.9

Secondary

Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months

Modified Intent-to-treat (mITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the primary efficacy variable. Patients with a baseline x-ray and a 12M x-ray are included.

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months

Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.

Posted

Number

Percentage of participants

12 months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months

Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)

Posted

Number

Percentage of Participants

Baseline, 12 months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months

Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)

Posted

Number

Percentage of Participants

Baseline, Month 24

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Mean Change in Height From Baseline

Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis

Posted

Mean

Standard Error

from Baseline to 12 months and 24 months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Number of Participants With First Clinical Vertebral Fracture

Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.

The ITT (intent to treat) population consisted of all subjects as randomized.

Posted

Number

Participants

24 months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Number of Participants With First Clinical Fracture

Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.

The ITT (intent to treat) population consisted of all subjects as randomized.

Posted

Number

Participants

24 months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Number of Participants With First Non-vertebral Fracture

Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.

The ITT (intent to treat) population consisted of all subjects as randomized.

Posted

Number

Participants

24 months

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Units

Secondary

Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)

Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)

Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.

Posted

Least Squares Mean

Standard Error

Percent change in BMD

Month 6, Month 12, Month 24

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Percentage Change From Baseline in Total Hip BMD (g/CM^2)

Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)

Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.

Posted

Least Squares Mean

Standard Error

Percent change in BMD

Month 6, Month 12, Month 24

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)

Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)

Intent-to-treat (ITT) population included all randomized subjects who had a baseline and at least one post-baseline assessment of the efficacy variable.

Posted

Least Squares Mean

Standard Error

Percent change in BMD

Month 6, Month 12, Month 24

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Secondary

Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits

The ITT, Intent to Treat population, includes all participants who received a single a dose of treatment and had data available for analysis. n = the number of subjects with evaluable measurements at visit, as determined by the efficacy window.

Posted

Mean

Standard Error

ng/mL

Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24

ID	Title	Description
OG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
OG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Zoledronic Acid	5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year			149	588	399	588
EG001	Placebo	100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year			154	611	256	611

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 affected588 at risk EG0011 affected611 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 affected588 at risk EG0017 affected611 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 affected588 at risk EG0015 affected611 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0014 affected611 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected588 at risk EG0011 affected611 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0011 affected611 at risk
Myocarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Exomphalos	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0011 affected611 at risk
Hyperthyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Heterophoria	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Retinal degeneration	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0013 affected611 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Faecaloma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Femoral hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0012 affected611 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Intestinal congestion	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0011 affected611 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Peritonitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Poor dental condition	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Adverse drug reaction	General disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Device failure	General disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Device occlusion	General disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0010 affected611 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0011 affected611 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0014 affected611 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Abdominal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0011 affected611 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Chronic sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Incision site abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected588 at risk EG0019 affected611 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0014 affected611 at risk
Vestibular neuronitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0011 affected611 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0013 affected611 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00016 affected588 at risk EG00110 affected611 at risk
Traumatic lung injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0013 affected611 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0011 affected611 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 affected588 at risk EG0013 affected611 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected588 at risk EG0015 affected611 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0011 affected611 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0004 affected588 at risk EG0012 affected611 at risk
Bladder cancer stage 0, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Hypopharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Lymph node cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Metastases to the mediastinum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0006 affected588 at risk EG0014 affected611 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Small cell lung cancer extensive stage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Alcohol induced persisting dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Balance disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Brain compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Cerebellar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Cerebral atrophy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected588 at risk EG0015 affected611 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Cervical root pain	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Encephalitis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Monoparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Parkinson's disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Radicular pain	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected588 at risk EG0013 affected611 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Encopresis	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Panic attack	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0012 affected611 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Urethral polyp	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0013 affected611 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0013 affected611 at risk
Epididymal cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected588 at risk EG0017 affected611 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0010 affected611 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected588 at risk EG0014 affected611 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Foreign body aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0012 affected611 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0012 affected611 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Walking disability	Social circumstances	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0011 affected611 at risk
Arterial haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Arteritis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0010 affected611 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected588 at risk EG0013 affected611 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Hypovolaemic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Intermittent claudication	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected588 at risk EG0011 affected611 at risk
Intra-abdominal haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected588 at risk EG0012 affected611 at risk
Varicose vein	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Vascular calcification	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk
Venous insufficiency	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected588 at risk EG0011 affected611 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA	Systematic Assessment	EG00040 affected588 at risk EG0015 affected611 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00040 affected588 at risk EG00113 affected611 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG00030 affected588 at risk EG00114 affected611 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG000143 affected588 at risk EG00121 affected611 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG00030 affected588 at risk EG00128 affected611 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00050 affected588 at risk EG00149 affected611 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000123 affected588 at risk EG00165 affected611 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00082 affected588 at risk EG00173 affected611 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00030 affected588 at risk EG00119 affected611 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000129 affected588 at risk EG00125 affected611 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00043 affected588 at risk EG00123 affected611 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00080 affected588 at risk EG00127 affected611 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00047 affected588 at risk EG00143 affected611 at risk

ID	Term
D010024	Osteoporosis
D016103	Spinal Fractures

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D013124	Spinal Injuries
D019567	Back Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

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