Trial Outcomes & Findings for The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease (NCT NCT00673075)

NCT ID: NCT00673075

Last Updated: 2010-09-28

Results Overview

Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

18 weeks post initiation of randomized treatment

Results posted on

2010-09-28

Participant Flow

The recruitment period was April 2008 to May 2009 at 35 US locations.

All patients went through a 4-week, single blind, metoprolol run-in phase before randomization.

Participant milestones

Participant milestones
Measure	Nebivolol Encapsulated Nebivolol	Carvedilol Encapsulated Carvedilol
Overall Study STARTED	21	18
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nebivolol n=21 Participants Encapsulated Nebivolol	Carvedilol n=18 Participants Encapsulated Carvedilol	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age Continuous	60.6 years STANDARD_DEVIATION 10.5 • n=5 Participants	66.6 years STANDARD_DEVIATION 10.3 • n=7 Participants	63.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 weeks post initiation of randomized treatment

Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)

Outcome measures

Outcome measures
Measure	Nebivolol n=13 Participants Encapsulated Nebivolol	Carvedilol n=12 Participants Encapsulated Carvedilol
Peripheral Diastolic Blood Pressure (DBP) Baseline	81.1 mmHg Standard Error 1.7	78.2 mmHg Standard Error 1.8
Peripheral Diastolic Blood Pressure (DBP) Post-baseline	78.0 mmHg Standard Error 2.4	79.3 mmHg Standard Error 2.6

SECONDARY outcome

Timeframe: 18 weeks post initiation of randomized treatment

Peripheral systolic blood pressure (SBP) at visit 13 (week 18)

Outcome measures

Outcome measures
Measure	Nebivolol n=13 Participants Encapsulated Nebivolol	Carvedilol n=12 Participants Encapsulated Carvedilol
Peripheral Systolic Blood Pressure (SBP) Baseline	135.1 mmHg Standard Error 2.5	136.9 mmHg Standard Error 2.4
Peripheral Systolic Blood Pressure (SBP) Post-Baseline	129.6 mmHg Standard Error 3.7	137.3 mmHg Standard Error 4.4

SECONDARY outcome

Timeframe: 18 weeks post-treatment

Proportion of Patients with Peripheral SBP \<140 mm Hg and DBP \<90 mm Hg at Week 18

Outcome measures

Outcome measures
Measure	Nebivolol n=13 Participants Encapsulated Nebivolol	Carvedilol n=12 Participants Encapsulated Carvedilol
Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18	11 participants	5 participants

SECONDARY outcome

Timeframe: 18 weeks post-treatment

Left ventricular ejection fraction (LVEF) (%) at Week 18

Outcome measures

Outcome measures
Measure	Nebivolol n=12 Participants Encapsulated Nebivolol	Carvedilol n=12 Participants Encapsulated Carvedilol
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 Baseline	61.43 percentage Standard Error 0.562	60.442 percentage Standard Error 1.125
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 Post baseline	61.93 percentage Standard Error 0.503	60.775 percentage Standard Error 0.614

Adverse Events

Nebivolol Combined Up-Titration and Stable-dose

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Carvedilol Combined Up-Titration and Stable-dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Nebivolol Down-Titration

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Carvedilol Down-Titration

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nebivolol Combined Up-Titration and Stable-dose n=21 participants at risk Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods	Carvedilol Combined Up-Titration and Stable-dose n=18 participants at risk Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods	Nebivolol Down-Titration n=12 participants at risk Encapsulated Nebivolol Down-Titration Period	Carvedilol Down-Titration n=11 participants at risk Encapsulated Carvedilol Down-Titration Period
Nervous system disorders Cerebrovascular accident	4.8% 1/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.

Other adverse events

Additional Information

John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism

Forest Laboratories

Phone: 1-201-427-8259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor can review results communications prior to public release \& can embargo communications re: results for 60 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential information. Upon sponsor's request, PI shall delete any proprietary info \& shall not include raw data in the publication. On sponsor's request, PI shall delay submission for any pub while sponsor files patent applications. Any publication will give recognition to Sponsor's support.
Publication restrictions are in place

Restriction type: OTHER

Measure	Nebivolol Combined Up-Titration and Stable-dose n=21 participants at risk Encapsulated Nebivolol Combined Up-Titration and Stable-Dose Periods	Carvedilol Combined Up-Titration and Stable-dose n=18 participants at risk Encapsulated Carvedilol Combined Up-Titration and Stable-Dose Periods	Nebivolol Down-Titration n=12 participants at risk Encapsulated Nebivolol Down-Titration Period	Carvedilol Down-Titration n=11 participants at risk Encapsulated Carvedilol Down-Titration Period
Ear and labyrinth disorders Cerumen impaction	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Endocrine disorders Hyperthyroidism	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Gastrointestinal disorders Nausea	9.5% 2/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	11.1% 2/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	9.1% 1/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Gastrointestinal disorders Constipation	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Gastrointestinal disorders Painful defaecatio	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Gastrointestinal disorders Chest pain	4.8% 1/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
General disorders Chest discomfort	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
General disorders Fatigue	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
General disorders Oedema peripheral	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	11.1% 2/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Sinusitis	14.3% 3/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Bronchitis	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Cellulitis	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Lower respiratory tract infection	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Nasopharyngitis	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Injury, poisoning and procedural complications Contusion	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Injury, poisoning and procedural complications Excoriation	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Injury, poisoning and procedural complications Wound	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Metabolism and nutrition disorders Dehydration	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Nervous system disorders Dizziness	9.5% 2/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	22.2% 4/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Nervous system disorders Headache	4.8% 1/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Nervous system disorders Dizziness postural	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Nervous system disorders Paraesthesia	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Psychiatric disorders Anxiety	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 1/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Vascular disorders Haematoma	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Otitis externa	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	9.1% 1/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Reproductive system and breast disorders Epididymitis	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	5.6% 1/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	9.1% 1/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Tinea infecton	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	8.3% 1/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.
Infections and infestations Upper respiratory tract infection	0.00% 0/21 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/18 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	8.3% 1/12 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.	0.00% 0/11 • The adverse event reporting timeframe was 16 months - from June,2008 until October, 2009.