MOBILE Study - A Study of Bonviva (Ibandronate) Regimens... | NCT00048061

Label	Type	Description	Intervention Names
Ibandronate 2.5 mg	Active Comparator	Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .	Drug: Ibandronate [Bonviva/Boniva] Dietary Supplement: Calcium Dietary Supplement: Vitamin D
Ibandronate 50/50 mg	Experimental	Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.	Drug: Ibandronate [Bonviva/Boniva] Dietary Supplement: Calcium Dietary Supplement: Vitamin D
Ibandronate 100 mg	Experimental	Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day	Drug: Ibandronate [Bonviva/Boniva] Dietary Supplement: Calcium Dietary Supplement: Vitamin D
Ibandronate 150 mg	Experimental	Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day

Name	Type	Description	Arm Group Labels	Other Names
Ibandronate [Bonviva/Boniva]	Drug	2.5mg po daily	Ibandronate 2.5 mg

Measure	Description	Time Frame
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density	Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.	From Baseline (Month 0) to Month 12

Measure	Description	Time Frame
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD	Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Irvine	California	92618	United States

ID	Title	Description
FG000	Ibandronate 2.5 mg	Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
FG001	Ibandronate 50/50 mg

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

Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density

Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.

The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.

Posted

Mean

Standard Deviation

Percent change

From Baseline (Month 0) to Month 12

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG003	Ibandronate 150 mg	Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Units	Counts
Participants	OG000314 OG001322 OG002306 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003.7427± 4.0149 OG0014.3395± 3.9557 OG0024.0328± 3.6815 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA		0.045		Mean Difference (Final Values)	0.615			2-Sided	95	0.013	1.216			Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.		Non-Inferiority or Equivalence	The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.

Secondary

Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD

Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.

Posted

Mean

Standard Deviation

Percent change

From Baseline (Month 0) to Month 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002

Secondary

Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD

The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Mean

Standard Deviation

g/cm2

From Baseline (Month 0) to Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD

Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Mean

Standard Deviation

Percent change

From Baseline (Month 0) to Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.

Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Mean

Standard Deviation

g/cm2

From Baseline (Month 0) to Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24

A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Number

Percentage of participants

Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24

Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Mean

Standard Deviation

Percent change

From Baseline (Month 0) to Months 3, 6, 12, 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Absolute Change In Baseline in Serum CTX to Months 12 and 24

Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).

The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.

Posted

Mean

Standard Deviation

ng/ml

From Baseline (Month 0) to Months 12 and 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Number of Participants With Any Adverse Events and Serious Adverse Event

An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.

Posted

Number

Participants

Up to Month 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Secondary

Number Of Participants With Marked Laboratory Abnormalities

Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].

The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.

Posted

Number

Participants

Up to Month 24

ID	Title	Description
OG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
OG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0003 affected395 at risk EG0011 affected396 at risk EG0022 affected396 at risk EG0032 affected396 at risk
Cellulitis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Lower respiratory tract Infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Appendicitis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Bronchial infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Dacryocystitis infective	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Ear infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Ear infection viral	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Erysipelas	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Gangrene	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Hematoma infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Laryngopharyngitis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Salmonellosis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Superinfection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Superinfection lung	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Urosepsis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0002 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Colonic polyp	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Gastrointestinal haemorrhage	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Appendicitis perforated	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Erosive duodenitis	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Reflux gastritis	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Myocardial ischemia	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0002 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0012 affected396 at risk EG0020 affected396 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0022 affected396 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Tachyarrhythmia	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0012 affected396 at risk EG0020 affected396 at risk EG003
Cardiac pacemaker malfunction	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Pain trauma activated	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Pubic rami fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Syncope	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0022 affected396 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Aphasia	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Dementia alzheimer's type	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Facial palsy	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Facial paresis	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Parkinsonism	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Sciatica	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Localised osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0014 affected396 at risk EG0021 affected396 at risk EG003
Back pain	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Spondylosis	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Toe deformity	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Hypertension	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0012 affected396 at risk EG0020 affected396 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Haematoma	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Hypotension	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Vascular pseudoaneurysm	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Depression	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0012 affected396 at risk EG0022 affected396 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Major depression	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0022 affected396 at risk EG003
Chronic obstructive airways disease	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Laryngeal polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0021 affected396 at risk EG003
Cystocele	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Urethral syndrome	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Cervical polyp	Reproductive system and breast disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Pelvic prolapse	Reproductive system and breast disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Hyperparathyroidism primary	Endocrine disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Chest pain	General disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Adverse drug reaction	General disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Pyrexia	General disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Cataract	Eye disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Diplopia	Eye disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Macular hole	Eye disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Cyst removal	Surgical and medical procedures	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0011 affected396 at risk EG0020 affected396 at risk EG003
Eventration procedure	Surgical and medical procedures	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Dermoid cyst of ovary	Congenital, familial and genetic disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected395 at risk EG0010 affected396 at risk EG0020 affected396 at risk EG003
Vestibular neuronitis	Ear and labyrinth disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected395 at risk EG0010 affected396 at risk EG0021 affected396 at risk EG003

ID	Term
D010024	Osteoporosis
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
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals
D001779	Blood Coagulation Factors
D001685	Biological Factors
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
BG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
BG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
BG003	Ibandronate 150 mg	Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ibandronate 2.5 mg	Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.	38	395	190	395
EG001	Ibandronate 50/50 mg	Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.	54	396	190	396
EG002	Ibandronate 100 mg	Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.	55	396	191	396
EG003	Ibandronate 150 mg	Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.	45	396	182	396