Trial Outcomes & Findings for Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women (NCT NCT00918749)

NCT ID: NCT00918749

Last Updated: 2015-06-29

Results Overview

Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

205 participants

Primary outcome timeframe

Month 4

Results posted on

2015-06-29

Participant Flow

Screening began 27 May 2009

Participant milestones

Participant milestones
Measure	150 mg 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Study STARTED	70	66	69
Overall Study ITT (Intent to Treat) Population	69	66	69
Overall Study COMPLETED	63	63	62
Overall Study NOT COMPLETED	7	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	150 mg 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Overall Study Adverse Event	1	0	1
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	5	3	5
Overall Study No Study Medication Taken	1	0	0

Baseline Characteristics

Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	Total n=205 Participants Total of all reporting groups	150 mg n=70 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Age, Continuous	57.5 years STANDARD_DEVIATION 7.0 • n=5 Participants	58.0 years STANDARD_DEVIATION 7.1 • n=4 Participants	58.3 years STANDARD_DEVIATION 7.2 • n=5 Participants	58.2 years STANDARD_DEVIATION 7.2 • n=7 Participants
Age, Customized < 65 years	55 participants n=5 Participants	165 participants n=4 Participants	57 participants n=5 Participants	53 participants n=7 Participants
Age, Customized 65 years thru <75 years	13 participants n=5 Participants	35 participants n=4 Participants	10 participants n=5 Participants	12 participants n=7 Participants
Age, Customized >= 75 years	1 participants n=5 Participants	4 participants n=4 Participants	2 participants n=5 Participants	1 participants n=7 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	205 Participants n=4 Participants	70 Participants n=5 Participants	66 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race/Ethnicity, Customized Asian (Oriental)	3 Participants n=5 Participants	16 Participants n=4 Participants	7 Participants n=5 Participants	6 Participants n=7 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	7 Participants n=4 Participants	0 Participants n=5 Participants	4 Participants n=7 Participants
Race/Ethnicity, Customized Caucasian	61 Participants n=5 Participants	174 Participants n=4 Participants	60 Participants n=5 Participants	53 Participants n=7 Participants
Race/Ethnicity, Customized Multi-Racial	1 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=5 Participants	3 Participants n=7 Participants
Race/Ethnicity, Customized Hawaiian/Pacific Islander	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants
Region of Enrollment United States	69 participants n=5 Participants	205 participants n=4 Participants	70 participants n=5 Participants	66 participants n=7 Participants

PRIMARY outcome

Timeframe: Month 4

Population: ITT Population

Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.

Outcome measures

Outcome measures
Measure	150 mg n=70 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population	-41.235 Percent Change from Baseline Standard Error 2.995	-44.832 Percent Change from Baseline Standard Error 3.012	-53.432 Percent Change from Baseline Standard Error 3.025

SECONDARY outcome

Timeframe: 2 months

Population: ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	-38.407 Percent Change from Baseline Standard Error 3.504	-33.641 Percent Change from Baseline Standard Error 3.538	-38.625 Percent Change from Baseline Standard Error 3.547

SECONDARY outcome

Timeframe: 3 months

Population: ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	-35.591 Percent Change from Baseline Standard Error 3.045	-35.203 Percent Change from Baseline Standard Error 3.034	-46.379 Percent Change from Baseline Standard Error 3.077

SECONDARY outcome

Timeframe: 2 months

Population: ITT Population

Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	-15.365 Percent Change from Baseline Standard Error 6.567	-0.837 Percent Change from Baseline Standard Error 6.631	-1.150 Percent Change from Baseline Standard Error 6.689

SECONDARY outcome

Timeframe: 3 months

Population: ITT Population

ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	-21.673 Percent Change from Baseline Standard Error 4.351	-20.555 Percent Change from Baseline Standard Error 4.326	-29.066 Percent Change from Baseline Standard Error 4.356

SECONDARY outcome

Timeframe: 4 months

Population: ITT Population

ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	-13.447 Percent Change from Baseline Standard Error 6.427	-7.942 Percent Change from Baseline Standard Error 6.464	-14.360 Percent Change from Baseline Standard Error 6.492

SECONDARY outcome

Timeframe: 2 months

Population: ITT Population

ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	-5.457 Percent Change from Baseline Standard Error 2.867	-2.349 Percent Change from Baseline Standard Error 2.895	-0.615 Percent Change from Baseline Standard Error 2.902

SECONDARY outcome

Timeframe: 3 months

Population: ITT Population

ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	-17.797 Percent Change from Baseline Standard Error 3.087	-12.831 Percent Change from Baseline Standard Error 3.075	-12.872 Percent Change from Baseline Standard Error 3.119

SECONDARY outcome

Timeframe: 4 months

Population: ITT Population

ITT Population

Outcome measures

Outcome measures
Measure	150 mg n=69 Participants 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 Participants 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 Participants 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	-20.885 Percent Change from Baseline Standard Error 2.956	-19.616 Percent Change from Baseline Standard Error 2.973	-23.710 Percent Change from Baseline Standard Error 2.986

Adverse Events

150 mg

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

75 mg

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

100 mg

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Grexan Wulff, Manager, Regulatory Affairs

Warner Chilcott

Phone: 973-442-3376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	150 mg n=69 participants at risk 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	75 mg n=66 participants at risk 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	100 mg n=69 participants at risk 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Gastrointestinal disorders Diarrhoea	15.9% 11/69 • Number of events 14 • 27 May 2009 thru 23 October 2009, 5 months	22.7% 15/66 • Number of events 20 • 27 May 2009 thru 23 October 2009, 5 months	21.7% 15/69 • Number of events 18 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Abdominal Pain	7.2% 5/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months	24.2% 16/66 • Number of events 18 • 27 May 2009 thru 23 October 2009, 5 months	20.3% 14/69 • Number of events 19 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Nausea	8.7% 6/69 • Number of events 8 • 27 May 2009 thru 23 October 2009, 5 months	9.1% 6/66 • Number of events 9 • 27 May 2009 thru 23 October 2009, 5 months	13.0% 9/69 • Number of events 12 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Vomiting	4.3% 3/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	9.1% 6/66 • Number of events 6 • 27 May 2009 thru 23 October 2009, 5 months	8.7% 6/69 • Number of events 6 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Constipation	5.8% 4/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months	13.6% 9/66 • Number of events 9 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Dyspepsia	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	6.1% 4/66 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 6 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Abdominal discomfort	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	5.8% 4/69 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Flatulence	7.2% 5/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	4.3% 3/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Abdominal Distension	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	1.5% 1/66 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Eructation	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	4.5% 3/66 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Abdominal Pain Upper	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	6.1% 4/66 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Abnormal Faeces	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Gastrointestinal disorders Frequent Bowel Movements	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	1.5% 1/66 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Myalgia	4.3% 3/69 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	10.6% 7/66 • Number of events 9 • 27 May 2009 thru 23 October 2009, 5 months	14.5% 10/69 • Number of events 13 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 6/69 • Number of events 8 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	10.1% 7/69 • Number of events 11 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Pain in Extremity	4.3% 3/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 8 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Back Pain	11.6% 8/69 • Number of events 8 • 27 May 2009 thru 23 October 2009, 5 months	9.1% 6/66 • Number of events 6 • 27 May 2009 thru 23 October 2009, 5 months	5.8% 4/69 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Neck Pain	2.9% 2/69 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/66 • 27 May 2009 thru 23 October 2009, 5 months	4.3% 3/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/66 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Muscle Spasms	4.3% 3/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	1.5% 1/66 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	8.7% 6/69 • Number of events 7 • 27 May 2009 thru 23 October 2009, 5 months	4.5% 3/66 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months
Nervous system disorders Headache	29.0% 20/69 • Number of events 24 • 27 May 2009 thru 23 October 2009, 5 months	22.7% 15/66 • Number of events 27 • 27 May 2009 thru 23 October 2009, 5 months	26.1% 18/69 • Number of events 25 • 27 May 2009 thru 23 October 2009, 5 months
Nervous system disorders Dizziness	5.8% 4/69 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	6.1% 4/66 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months
General disorders Chills	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	7.6% 5/66 • Number of events 6 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months
General disorders Pain	8.7% 6/69 • Number of events 7 • 27 May 2009 thru 23 October 2009, 5 months	10.6% 7/66 • Number of events 10 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 6 • 27 May 2009 thru 23 October 2009, 5 months
General disorders Pyrexia	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months
General disorders Fatigue	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	4.3% 3/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months
General disorders Chest Discomfort	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	1.5% 1/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
General disorders Oedema Peripheral	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/66 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	7.2% 5/69 • Number of events 5 • 27 May 2009 thru 23 October 2009, 5 months
Respiratory, thoracic and mediastinal disorders Cough	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months
Respiratory, thoracic and mediastinal disorders Oopharyngeal pain	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/66 • 27 May 2009 thru 23 October 2009, 5 months	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/66 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Infections and infestations Upper Respiratory Tract Infection	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/66 • 27 May 2009 thru 23 October 2009, 5 months	4.3% 3/69 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months
Infections and infestations Viral Infection	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	4.5% 3/66 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months
Psychiatric disorders Insomnia	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 3 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months
Metabolism and nutrition disorders Decreased Appetite	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	6.1% 4/66 • Number of events 4 • 27 May 2009 thru 23 October 2009, 5 months	2.9% 2/69 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months
Vascular disorders Flushing	0.00% 0/69 • 27 May 2009 thru 23 October 2009, 5 months	3.0% 2/66 • Number of events 2 • 27 May 2009 thru 23 October 2009, 5 months	1.4% 1/69 • Number of events 1 • 27 May 2009 thru 23 October 2009, 5 months