Evaluation of a Flushing ASsessment Tool (FAST) in Subjects Receiving Niacin Extended-release Plus Aspirin

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00630877
• Collaborator: (none)
• Enrollment: 276
• Locations: 41
• Arms: 3
• Duration (Months): 4
• Patients Per Site: 6.7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The primary purpose of this study was to evaluate the psychometric characteristics (reliability, validity, and responsiveness) of a Flushing ASsessment Tool (FAST) in subjects receiving niacin extended-release (NER) plus aspirin (ASA) daily for 6 weeks.

The FAST is a questionnaire that was developed to provide a detailed assessment of flushing symptoms and their impact in patients receiving niacin therapy. The effect of aspirin on flushing symptoms, as measured by the FAST, was also evaluated.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: Niacin extended-release (NER); Drug: Niacin extended-release (NER) placebo; Drug: Aspirin (ASA); Drug: Aspirin (ASA) placebo	Phase 3

Detailed Description

This study was designed to evaluate the psychometric characteristics of the FAST questionnaire.

The FAST is a self-administered questionnaire, completed using a hand-held electronic data capture device (LogPad e-diary). Subjects recorded the start and stop date and time of each flushing event, the presence and severity of individual flushing symptoms (redness, warmth, tingling and/or itching), and an overall assessment of their flushing experience.

Evaluation of the psychometric characteristics of the FAST was based on 3 primary data analyses: 1 ) test-retest reliability based on the intraclass correlation coefficient; 2) construct validity based on Spearman correlation coefficients; and 3) responsiveness based on changes in FAST scores. The mean and maximum severity of flushing events, as measured by the FAST, were the primary variables evaluated in each of the 3 data analyses mentioned above. Psychometric analyses were performed blinded to treatment group assignment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Parallel, Multicenter, Placebo-controlled, Prospective Study to Evaluate the Functionality of the Flushing ASsessment Tool (FAST) in Subjects Administered Niaspan® Plus Acetylsalicylic Acid (ASA), Niaspan® Plus ASA Placebo or Niaspan® Placebo Plus ASA Placebo Daily for Six Weeks
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NER/ASA	Drug: Niacin extended-release (NER); Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg; Other Names: ABT-919 Niaspan ; Drug: Aspirin (ASA); Tablets (325 mg) administered once daily for 6 weeks; Other Names: acetylsalicylic acid
Experimental: NER/ASA Placebo	Drug: Niacin extended-release (NER); Tablets administered once daily for 6 weeks; titrated to a maximum dose of 2000 mg; Other Names: ABT-919 Niaspan ; Drug: Aspirin (ASA) placebo; Tablets administered once daily for 6 weeks
Experimental: NER Placebo/ASA Placebo	Drug: Niacin extended-release (NER) placebo; Tablets administered once daily for 6 weeks; Drug: Aspirin (ASA) placebo; Tablets administered once daily for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score [Week 1 to Week 2]

   Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.

2. FAST Test-retest Reliability--maximum Flushing Severity Score [Week 1 to Week 2]

   Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.

3. FAST Cross-sectional Construct Validity--mean Flushing Severity Score [Week 1]

   The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.

4. FAST Cross-sectional Construct Validity--maximum Flushing Severity Score [Week 1]

   The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.

5. FAST Longitudinal Construct Validity--mean Flushing Severity Score [Week 1 to Week 2]

   The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).

6. FAST Longitudinal Construct Validity--maximum Flushing Severity Score [Week 1 to Week 2]

   The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).

7. FAST Responsiveness--mean Flushing Severity Score [Study start to Day 43]

   The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.

8. FAST Responsiveness--maximum Flushing Severity Score [Study start to Day 43]

   The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.

Secondary Outcome Measures

1. Maximum Severity of Flushing Events Overall During the Study [Week 1 to Week 6]

   The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must be 18 years of age or older.

• If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.

• Have dyslipidemia as demonstrated by laboratory results.

Exclusion Criteria:

• Have glycosylated hemoglobin (HbA1c) >= 9.0%.

• Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate [GFR] < 30 mL/minute, as calculated from creatinine clearance).

• Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.

• Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.

• Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.

• Have symptomatic heart failure defined as dyspnea at rest or with exertion (mild peripheral edema is not exclusionary).

• Have a systolic blood pressure measurement of > 180 mmHg or a diastolic blood pressure measurement of > 110 mmHg at the Screening or Baseline Visit

• Have active gout or uric acid >= 11 mg/dL.

• Have a history of hepatitis (acute or chronic), obstructive liver disease, or alanine aminotransferase (ALT; serum glutamic pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase [SGOT]) values >= 1.3 times the upper limit of normal (ULN) at the Screening Visit.

• Have creatine phosphokinase (CPK) >= 3 x ULN at the Screening Visit.

• Have used an investigational study drug or participated in an investigational study within 30 days of the Screening Visit.

• Have a health condition or laboratory abnormality (inclusive of clinically significant laboratory results at Screening Visit), which, in the opinion of the Investigator, may be adversely affected by the procedures or study medications in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35209
2		Anaheim	California	United States	92801
3		Walnut Creek	California	United States	94598
4		Denver	Colorado	United States	80212
5		Brooksville	Florida	United States	34613
6		Daytona Beach	Florida	United States	32127
7		Hollywood	Florida	United States	33023
8		Jacksonville	Florida	United States	32216
9		Largo	Florida	United States	33770
10		Miami	Florida	United States	33126
11		Pembroke Pines	Florida	United States	33026
12		Boise	Idaho	United States	83704
13		Chicago	Illinois	United States	60610
14		Arkansas City	Kansas	United States	67005
15		Topeka	Kansas	United States	66608
16		Wichita	Kansas	United States	67203
17		Wichita	Kansas	United States	67207
18		St Louis	Missouri	United States	63141
19		St. Louis	Missouri	United States	63141
20		Las Vegas	Nevada	United States	89146
21		Durham	North Carolina	United States	27704
22		High Point	North Carolina	United States	27262
23		Salisbury	North Carolina	United States	28144
24		Statesville	North Carolina	United States	28677
25		Cincinnati	Ohio	United States	45242
26		Portland	Oregon	United States	97239
27		Duncansville	Pennsylvania	United States	16635
28		Harleysville	Pennsylvania	United States	19438
29		Pittsburgh	Pennsylvania	United States	15206
30		Greer	South Carolina	United States	29651
31		Austin	Texas	United States	78752
32		Carrollton	Texas	United States	75006
33		Dallas	Texas	United States	75251
34		San Antonio	Texas	United States	78217
35		San Antonio	Texas	United States	78224
36		Magna	Utah	United States	84044
37		Murray	Utah	United States	84107
38		Sandy	Utah	United States	84094
39		Gig Harbor	Washington	United States	98335
40		Menomonee Falls	Wisconsin	United States	53051
41		Milwaukee	Wisconsin	United States	53209

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Roopal Thakkar, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00630877
• Other Study ID Numbers: M10-229
• First Posted: Mar 7, 2008
• Last Update Posted: Oct 9, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Dyslipidemias; Flushing; Aspirin; Niacin; Niacinamide; Nicotinic Acids

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled at 41 sites in the United States between February and June, 2008.
Pre-assignment Detail	Of the 276 subjects that were randomized, 5 discontinued from the study prior to receiving study drug due to withdrawal of consent (2), death in the family (1), positive pregnancy test (1), and lost to follow up (1).

Arm/Group Title	NER/ASA	NER/ASA Placebo	NER Placebo/ASA Placebo
Arm/Group Description	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily	Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
Period Title: Overall Study
STARTED	91	90	90
COMPLETED	72	75	80
NOT COMPLETED	19	15	10

Baseline Characteristics

Arm/Group Title	NER/ASA	NER/ASA Placebo	NER Placebo/ASA Placebo	Total
Arm/Group Description	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily	Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily	Total of all reporting groups
Overall Participants	91	90	90	271
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.1 (11.68)	53.7 (12.74)	52.9 (12.26)	53.6 (12.20)
Sex: Female, Male (Count of Participants)
Female	42 46.2%	41 45.6%	42 46.7%	125 46.1%
Male	49 53.8%	49 54.4%	48 53.3%	146 53.9%
Region of Enrollment (participants) [Number]
United States	91 100%	90 100%	90 100%	271 100%

Outcome Measures

1. Primary Outcome

Title	Flushing ASsessment Tool (FAST) Test-retest Reliability--mean Flushing Severity Score
Description	Test-retest reliability of the mean flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Time Frame	Week 1 to Week 2

Outcome Measure Data

Analysis Population Description

Subjects with stable flushing symptoms from Week 1 to Week 2.

Arm/Group Title	Subjects With Stable Flushing Symptoms
Arm/Group Description	Subjects whose flushing symptoms remained stable from Week 1 to Week 2
Measure Participants	174
Number [Intraclass correlation coefficient]	0.75

2. Secondary Outcome

Title	Maximum Severity of Flushing Events Overall During the Study
Description	The severity of flushing events was assessed as none, mild, moderate, severe, or very severe using the FAST. The maximum severity of flushing events overall during the study was compared among treatment groups.
Time Frame	Week 1 to Week 6

Outcome Measure Data

Analysis Population Description

m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.

Arm/Group Title	NER/ASA	NER/ASA Placebo	NER Placebo/ASA Placebo
Arm/Group Description	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily	Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
Measure Participants	90	90	89
None	26	14	37
Mild	23	16	38
None/Mild	49	30	75
Moderate	34	31	22
Severe	17	32	2
Very Severe	0	7	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms, NER/ASA Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Primary Outcome

Title	FAST Test-retest Reliability--maximum Flushing Severity Score
Description	Test-retest reliability of the maximum flushing severity score was evaluated. The intraclass correlation coefficient comparing flushing severity scores for Week 1 and Week 2 was examined to determine test-retest reliability. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe.
Time Frame	Week 1 to Week 2

Outcome Measure Data

Analysis Population Description

Subjects with stable flushing symptoms from Week 1 to Week 2.

Arm/Group Title	Subjects With Stable Flushing Symptoms
Arm/Group Description	Subjects whose flushing symptoms remained stable from Week 1 to Week 2
Measure Participants	174
Number [Intraclass correlation coefficient]	0.40

4. Primary Outcome

Title	FAST Cross-sectional Construct Validity--mean Flushing Severity Score
Description	The relationship between mean flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.

Arm/Group Title	Modified Intent-to-Treat (m-ITT) Population
Arm/Group Description	All subjects who received study drug and had an entry in the e-diary.
Measure Participants	269
Number [Spearman correlation coefficient]	0.64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Spearman rank-order correlation
	Comments

5. Primary Outcome

Title	FAST Cross-sectional Construct Validity--maximum Flushing Severity Score
Description	The relationship between maximum flushing severity and overall flushing troublesomeness was evaluated by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Overall flushing troublesomeness was assessed using the FAST on a scale of 1 to 10, with 10 being the most troublesome.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.

Arm/Group Title	Modified Intent-to-Treat (m-ITT) Population
Arm/Group Description	All subjects who received study drug and had an entry in the e-diary.
Measure Participants	269
Number [Spearman correlation coefficient]	0.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Spearman rank-order correlation
	Comments

6. Primary Outcome

Title	FAST Longitudinal Construct Validity--mean Flushing Severity Score
Description	The relationship between the change in mean flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
Time Frame	Week 1 to Week 2

Outcome Measure Data

Analysis Population Description

m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.

Arm/Group Title	Modified Intent-to-Treat (m-ITT) Population
Arm/Group Description	All subjects who received study drug and had an entry in the e-diary.
Measure Participants	269
Number [Spearman correlation coefficient]	-0.44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Spearman rank-order correlation
	Comments

7. Primary Outcome

Title	FAST Longitudinal Construct Validity--maximum Flushing Severity Score
Description	The relationship between the change in maximum flushing severity scores from Week 1 to Week 2, and the subject-rated overall treatment effect scale administered at Week 2, was assessed by examining the Spearman rank-order correlation. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. The overall treatment effect was assessed on a scale of 1 (symptoms are worse since study start), 2 (symptoms are about the same since study start), or 3 (symptoms are better since study start).
Time Frame	Week 1 to Week 2

Outcome Measure Data

Analysis Population Description

m-ITT population, defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 entry in the e-diary.

Arm/Group Title	Modified Intent-to-Treat (m-ITT) Population
Arm/Group Description	All subjects who received study drug and had an entry in the e-diary.
Measure Participants	269
Number [Spearman correlation coefficient]	-0.42

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Spearman rank-order correlation
	Comments

8. Primary Outcome

Title	FAST Responsiveness--mean Flushing Severity Score
Description	The change in mean flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in mean flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Time Frame	Study start to Day 43

Outcome Measure Data

Analysis Population Description

Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.

Arm/Group Title	Responders	Nonresponders
Arm/Group Description	Subjects whose flushing symptoms improved from study start to Day 43.	Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
Measure Participants	46	159
Number [Units on a scale]	-0.51	0.15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms, NER/ASA Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Independent groups t-test
	Comments

9. Primary Outcome

Title	FAST Responsiveness--maximum Flushing Severity Score
Description	The change in maximum flushing severity scores from study start to Day 43 was compared in subjects classified as responders vs. nonresponders. Flushing severity was assessed using the FAST on a scale of 1 to 10, with 10 being the most severe. Changes in maximum flushing severity scores were negative if flushing symptoms improved and positive if flushing symptoms worsened.
Time Frame	Study start to Day 43

Outcome Measure Data

Analysis Population Description

Subjects in the m-ITT population were classified as responders (improved flushing symptoms) or nonresponders (no change or worsened flushing symptoms) based on changes in flushing symptoms from study start to Day 43.

Arm/Group Title	Responders	Nonresponders
Arm/Group Description	Subjects whose flushing symptoms improved from study start to Day 43.	Subjects whose flushing symptoms did not change or worsened from study start to Day 43.
Measure Participants	46	159
Number [Units on a scale]	-1.85	-0.18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Stable Flushing Symptoms, NER/ASA Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Independent groups t-test
	Comments

Adverse Events

Arm/Group Title	NER/ASA		NER/ASA Placebo		NER Placebo/ASA Placebo
Arm/Group Description	Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) 325 mg once daily		Niacin extended-release (NER) titrated to 2000 mg plus aspirin (ASA) placebo once daily		Niacin extended-release (NER) placebo plus aspirin (ASA) placebo once daily
All Cause Mortality
	NER/ASA		NER/ASA Placebo		NER Placebo/ASA Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	NER/ASA		NER/ASA Placebo		NER Placebo/ASA Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/ (NaN)		1/ (NaN)		2/ (NaN)
Cardiac disorders
Myocardial infarction	0/91 (0%)	0	1/90 (1.1%)	1	0/90 (0%)	0
Congenital, familial and genetic disorders
Adenomatous polyposis	0/91 (0%)	0	0/90 (0%)	0	1/90 (1.1%)	1
General disorders
Non-cardiac chest pain	1/91 (1.1%)	1	0/90 (0%)	0	0/90 (0%)	0
Renal and urinary disorders
Right renal cyst	0/91 (0%)	0	0/90 (0%)	0	1/90 (1.1%)	1
Nephrolithiasis	0/91 (0%)	0	0/90 (0%)	0	1/90 (1.1%)	1
Other (Not Including Serious) Adverse Events
	NER/ASA		NER/ASA Placebo		NER Placebo/ASA Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/ (NaN)		80/ (NaN)		60/ (NaN)
Gastrointestinal disorders
Diarrhea	2/91 (2.2%)		7/90 (7.8%)		5/90 (5.6%)
Nausea	4/91 (4.4%)		2/90 (2.2%)		2/90 (2.2%)
Vomiting	3/91 (3.3%)		2/90 (2.2%)		2/90 (2.2%)
General disorders
Fatigue	1/91 (1.1%)		2/90 (2.2%)		0/90 (0%)
Peripheral edema	2/91 (2.2%)		0/90 (0%)		0/90 (0%)
Infections and infestations
Sinusitis	1/91 (1.1%)		2/90 (2.2%)		1/90 (1.1%)
Upper respiratory tract infection	3/91 (3.3%)		2/90 (2.2%)		2/90 (2.2%)
Injury, poisoning and procedural complications
Muscle strain	2/91 (2.2%)		1/90 (1.1%)		0/90 (0%)
Metabolism and nutrition disorders
Hyperglycemia	0/91 (0%)		2/90 (2.2%)		0/90 (0%)
Musculoskeletal and connective tissue disorders
Muscle spasms	1/91 (1.1%)		2/90 (2.2%)		0/90 (0%)
Pain in extremity	2/91 (2.2%)		0/90 (0%)		0/90 (0%)
Nervous system disorders
Headache	3/91 (3.3%)		1/90 (1.1%)		7/90 (7.8%)
Psychiatric disorders
Insomnia	0/91 (0%)		0/90 (0%)		2/90 (2.2%)
Skin and subcutaneous tissue disorders
Urticaria	2/91 (2.2%)		1/90 (1.1%)		0/90 (0%)
Vascular disorders
Flushing	68/91 (74.7%)		78/90 (86.7%)		56/90 (62.2%)
Hypertension	2/91 (2.2%)		0/90 (0%)		0/90 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Provide ABBOTT at least sixty (60) days prior to submission for review, ABBOTT shall return comments within sixty (60) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.