Trial Outcomes & Findings for Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood (NCT NCT00300482)

NCT ID: NCT00300482

Last Updated: 2009-06-10

Results Overview

\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1445 participants
• Primary outcome timeframe: Baseline to 12 Weeks
• Results posted on: 2009-06-10

Participant Flow

Six subjects were randomized but not treated: 1 was lost to follow-up, 1 was randomized but deemed ineligible, 1 was withdrawn at the investigator's discretion, and 3 withdrew consent.

Participant milestones

Measure	ABT-335 + 10 mg Rosuvastatin ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 ABT-335 monotherapy once daily	10 mg Rosuvastatin 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin 40 mg rosuvastatin monotherapy once daily
Overall Study STARTED	261	261	259	261	266	131
Overall Study COMPLETED	220	220	208	237	243	115
Overall Study NOT COMPLETED	41	41	51	24	23	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood

Baseline characteristics by cohort

Measure	ABT-335 + 10 mg Rosuvastatin n=261 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=261 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=259 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=261 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=266 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=131 Participants 40 mg rosuvastatin monotherapy once daily	Total n=1439 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	206 Participants n=5 Participants	209 Participants n=7 Participants	209 Participants n=5 Participants	222 Participants n=4 Participants	217 Participants n=21 Participants	103 Participants n=8 Participants	1166 Participants n=8 Participants
Age, Categorical >=65 years	55 Participants n=5 Participants	52 Participants n=7 Participants	50 Participants n=5 Participants	39 Participants n=4 Participants	49 Participants n=21 Participants	28 Participants n=8 Participants	273 Participants n=8 Participants
Sex: Female, Male Female	148 Participants n=5 Participants	131 Participants n=7 Participants	152 Participants n=5 Participants	130 Participants n=4 Participants	124 Participants n=21 Participants	65 Participants n=8 Participants	750 Participants n=8 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	130 Participants n=7 Participants	107 Participants n=5 Participants	131 Participants n=4 Participants	142 Participants n=21 Participants	66 Participants n=8 Participants	689 Participants n=8 Participants
Region of Enrollment North America	261 participants n=5 Participants	261 participants n=7 Participants	259 participants n=5 Participants	261 participants n=4 Participants	266 participants n=21 Participants	131 participants n=8 Participants	1439 participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward

[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=252 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=249 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=242 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=252 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=255 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=127 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in Triglycerides From Baseline to Final Visit	-47.1 percent change Standard Error 1.81	-42.9 percent change Standard Error 1.82	-32.6 percent change Standard Error 1.84	-24.4 percent change Standard Error 1.81	-25.6 percent change Standard Error 1.80	-32.1 percent change Standard Error 2.48

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline HDL-C value and at least 1 postbaseline HDL-C value, last observation carried forward

[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=224 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=225 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=220 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=239 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=236 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=115 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit	20.3 percent change Standard Error 1.36	19.0 percent change Standard Error 1.35	15.0 percent change Standard Error 1.37	8.5 percent change Standard Error 1.32	10.3 percent change Standard Error 1.32	9.3 percent change Standard Error 1.85

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline LDL-C value and at least 1 postbaseline LDL-C value, last observation carried forward

[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=231 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=230 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=223 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=243 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=238 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=120 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit	-37.2 percent change Standard Error 1.21	-38.8 percent change Standard Error 1.21	-6.5 percent change Standard Error 1.22	-38.0 percent change Standard Error 1.18	-45.0 percent change Standard Error 1.19	-50.6 percent change Standard Error 1.64

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline non-HDL-C value and at least 1 postbaseline non-HDL-C value, LOCF

[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=224 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=225 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=220 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=238 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=236 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=115 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in Non-low-density Lipoprotein Cholesterol (Non-HDL-C)From Baseline to Final Visit	-44.7 percent change Standard Error 1.05	-45.3 percent change Standard Error 1.04	-18.5 percent change Standard Error 1.06	-39.8 percent change Standard Error 1.02	-45.8 percent change Standard Error 1.02	-51.5 percent change Standard Error 1.43

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline VLDL-C value and at least 1 postbaseline VLDL-C value, LOCF

[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=243 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=237 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=235 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=244 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=243 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=126 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit	-55.8 percent change Standard Error 3.08	-50.6 percent change Standard Error 3.10	-31.9 percent change Standard Error 3.13	-41.0 percent change Standard Error 3.07	-42.1 percent change Standard Error 3.07	-49.1 percent change Standard Error 4.17

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline total cholesterol value and at least 1 postbaseline total cholesterol value, LOCF

[(Week 12 total cholesterol minus baseline total cholesterol)/baseline total cholesterol] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=252 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=249 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=242 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=252 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=255 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=127 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in Total Cholesterol From Baseline to Final Visit	-34.4 percent change Standard Error 0.82	-35.7 percent change Standard Error 0.83	-13.5 percent change Standard Error 0.84	-32.5 percent change Standard Error 0.82	-37.3 percent change Standard Error 0.82	-42.7 percent change Standard Error 1.13

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline ApoB and at least 1 postbaseline ApoB value, LOCF

[(Week 12 Apo B minus baseline Apo B)/baseline Apo B] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=252 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=244 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=239 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=248 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=252 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=123 Participants 40 mg rosuvastatin monotherapy once daily
Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit	-39.2 percent change Standard Error 1.04	-39.2 percent change Standard Error 1.05	-16.2 percent change Standard Error 1.06	-34.1 percent change Standard Error 1.04	-39.6 percent change Standard Error 1.03	-45.0 percent change Standard Error 1.45

SECONDARY outcome

Timeframe: Baseline to 12 Weeks

Population: All randomized subjects with a baseline hsCRP value and at least 1 postbaseline hsCRP value, LOCF

[(Week 12 hsCRP minus baseline hsCRP)/baseline hsCRP] x 100

Outcome measures

Measure	ABT-335 + 10 mg Rosuvastatin n=252 Participants ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin n=246 Participants ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 n=241 Participants ABT-335 monotherapy once daily	10 mg Rosuvastatin n=249 Participants 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin n=254 Participants 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin n=125 Participants 40 mg rosuvastatin monotherapy once daily
Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit	-33.8 percent change Inter-Quartile Range 16.87 • Interval -52.4 to 0.2	-40.8 percent change Inter-Quartile Range 17.01 • Interval -59.9 to -10.3	-12.1 percent change Inter-Quartile Range 17.20 • Interval -40.1 to 22.7	-22.9 percent change Inter-Quartile Range 16.92 • Interval -48.1 to 12.3	-29.9 percent change Inter-Quartile Range 16.78 • Interval -53.8 to 4.1	-33.1 percent change Inter-Quartile Range 23.31 • Interval -59.0 to -6.4

Adverse Events

ABT-335 + 10 mg Rosuvastatin

Serious events: 10 serious events

Other events: 126 other events

Deaths: 0 deaths

ABT-335 + 20 mg Rosuvastatin

Serious events: 3 serious events

Other events: 114 other events

Deaths: 0 deaths

ABT-335

Serious events: 10 serious events

Other events: 117 other events

Deaths: 0 deaths

10 mg Rosuvastatin

Serious events: 3 serious events

Other events: 109 other events

Deaths: 0 deaths

20 mg Rosuvastatin

Serious events: 7 serious events

Other events: 110 other events

Deaths: 0 deaths

40 mg Rosuvastatin

Serious events: 2 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Measure	ABT-335 + 10 mg Rosuvastatin ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 ABT-335 monotherapy once daily	10 mg Rosuvastatin 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin 40 mg rosuvastatin monotherapy once daily
Cardiac disorders Coronary artery disease	0.38% 1/261	0.38% 1/261	0.39% 1/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Cardiac disorders Myocardial infarction	0.77% 2/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Cardiac disorders Myocardial ischaemia	0.00% 0/261	0.38% 1/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Cardiac disorders Pericarditis	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Gastrointestinal disorders Colitis	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.38% 1/261	0.00% 0/266	0.00% 0/131
Gastrointestinal disorders Pancreatitis acute	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
General disorders Chest pain	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
General disorders Non-cardiac chest pain	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Bronchitis	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Gastrointestinal disorders Diverticulitis	0.00% 0/261	0.38% 1/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Gastroenteritis	0.38% 1/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Kidney infection	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Pneumonia	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Pyothorax	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Sepsis	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.38% 1/261	0.00% 0/266	0.00% 0/131
Infections and infestations Septic shock	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Infections and infestations Urinary tract infection	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.38% 1/261	0.00% 0/266	0.00% 0/131
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Musculoskeletal and connective tissue disorders Osteonecrosis	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/261	0.00% 0/261	0.77% 2/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Nervous system disorders Guillain-Barre syndrome	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Nervous system disorders Presyncope	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Nervous system disorders Syncope	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Renal and urinary disorders Nephrolithiasis	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.38% 1/266	0.00% 0/131
Renal and urinary disorders Renal failure	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Renal and urinary disorders Renal pain	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.76% 1/131
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/261	0.00% 0/261	0.00% 0/259	0.38% 1/261	0.00% 0/266	0.00% 0/131
Respiratory, thoracic and mediastinal disorders Asthma	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Respiratory, thoracic and mediastinal disorders Dyspnea	0.38% 1/261	0.00% 0/261	0.00% 0/259	0.00% 0/261	0.00% 0/266	0.00% 0/131
Vascular disorders Peripheral vascular disorder	0.00% 0/261	0.00% 0/261	0.39% 1/259	0.00% 0/261	0.00% 0/266	0.76% 1/131

Other adverse events

Measure	ABT-335 + 10 mg Rosuvastatin ABT-335 + 10 mg rosuvastatin combination therapy once daily	ABT-335 + 20 mg Rosuvastatin ABT-335 + 20 mg rosuvastatin combination therapy once daily	ABT-335 ABT-335 monotherapy once daily	10 mg Rosuvastatin 10 mg rosuvastatin monotherapy once daily	20 mg Rosuvastatin 20 mg rosuvastatin monotherapy once daily	40 mg Rosuvastatin 40 mg rosuvastatin monotherapy once daily
Gastrointestinal disorders Constipation	4.2% 11/261	2.7% 7/261	3.5% 9/259	2.3% 6/261	3.4% 9/266	3.1% 4/131
Gastrointestinal disorders Diarrhea	2.7% 7/261	3.1% 8/261	2.7% 7/259	2.3% 6/261	3.0% 8/266	4.6% 6/131
Gastrointestinal disorders Dyspepsia	1.9% 5/261	5.0% 13/261	3.5% 9/259	3.4% 9/261	2.6% 7/266	3.8% 5/131
Gastrointestinal disorders Nausea	3.4% 9/261	5.4% 14/261	4.6% 12/259	4.6% 12/261	4.1% 11/266	3.8% 5/131
Gastrointestinal disorders Stomach discomfort	1.1% 3/261	0.77% 2/261	1.2% 3/259	1.9% 5/261	1.1% 3/266	3.8% 5/131
General disorders Fatigue	4.6% 12/261	4.6% 12/261	2.3% 6/259	2.7% 7/261	2.6% 7/266	3.1% 4/131
General disorders Pain	2.7% 7/261	0.77% 2/261	3.1% 8/259	2.7% 7/261	0.75% 2/266	4.6% 6/131
Infections and infestations Nasopharyngitis	3.8% 10/261	3.4% 9/261	2.3% 6/259	5.4% 14/261	3.0% 8/266	3.8% 5/131
Infections and infestations Sinusitis	3.4% 9/261	2.3% 6/261	3.9% 10/259	0.77% 2/261	1.1% 3/266	2.3% 3/131
Infections and infestations Upper respiratiory tract infection	4.6% 12/261	4.6% 12/261	3.9% 10/259	1.9% 5/261	2.3% 6/266	3.1% 4/131
Investigations Alanine aminotransferase increased	1.5% 4/261	3.4% 9/261	1.5% 4/259	0.77% 2/261	0.75% 2/266	1.5% 2/131
Investigations Aspartate aminotransferase increased	1.5% 4/261	3.1% 8/261	1.2% 3/259	0.77% 2/261	0.38% 1/266	1.5% 2/131
Investigations Blood creatine phosphokinase increased	1.9% 5/261	1.9% 5/261	1.5% 4/259	1.1% 3/261	2.6% 7/266	3.1% 4/131
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 11/261	3.1% 8/261	3.9% 10/259	3.8% 10/261	3.4% 9/266	6.9% 9/131
Musculoskeletal and connective tissue disorders Back pain	5.7% 15/261	5.7% 15/261	6.6% 17/259	6.5% 17/261	6.0% 16/266	4.6% 6/131
Musculoskeletal and connective tissue disorders Muscle spasms	2.7% 7/261	2.3% 6/261	1.2% 3/259	3.8% 10/261	4.5% 12/266	3.1% 4/131
Musculoskeletal and connective tissue disorders Myalgia	3.8% 10/261	2.7% 7/261	2.7% 7/259	5.7% 15/261	3.4% 9/266	6.9% 9/131
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/261	0.77% 2/261	1.2% 3/259	0.38% 1/261	0.00% 0/266	3.1% 4/131
Musculoskeletal and connective tissue disorders Pain in extremity	1.9% 5/261	3.1% 8/261	5.4% 14/259	5.4% 14/261	3.4% 9/266	4.6% 6/131
Nervous system disorders Dizziness	4.6% 12/261	3.4% 9/261	4.6% 12/259	1.5% 4/261	2.3% 6/266	0.00% 0/131
Nervous system disorders Headache	15.3% 40/261	8.8% 23/261	11.6% 30/259	12.6% 33/261	16.5% 44/266	15.3% 20/131
Psychiatric disorders Insomnia	2.3% 6/261	3.1% 8/261	2.3% 6/259	1.1% 3/261	1.1% 3/266	2.3% 3/131
Respiratory, thoracic and mediastinal disorders Cough	2.3% 6/261	1.5% 4/261	2.3% 6/259	1.1% 3/261	0.38% 1/266	3.1% 4/131
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.1% 3/261	0.77% 2/261	1.2% 3/259	2.7% 7/261	1.1% 3/266	3.1% 4/131

Additional Information

Medical Information Specialist

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall be so restricted after the expiration of twelve (12) months from completion of the studies at all sites. Any presentation or publication to be submitted to Sponsor (in draft of the same) for Sponsor review and comment.
• Publication restrictions are in place

Restriction type: OTHER