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Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) (TEAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00259610
Recruitment Status : Completed
First Posted : November 29, 2005
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborators:
Amgen
Barr Laboratories
Pfizer
Information provided by (Responsible Party):
University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: methotrexate
Drug: sulfasalazine
Drug: hydroxychloroquine
Drug: etanercept
Enrollment 755
Recruitment Details Recruitment began in May 2004 and concluded in January 2007.
Pre-assignment Details This study had a screening period of 1-3 days, Patients were excluded for various reasons, including, laboratory exclusions, Positive TB test, and Cataract/visual defect.
Arm/Group Title MTX + Active Etanercept MTX+ Active SSZ +HCQ MTX + Placebo Entaneracept MTX + Placebo SSZ + HCQ(ST)
Hide Arm/Group Description Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection methotrexate (MTX)20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
Period Title: Overall Study
Started 244 132 255 124
Completed 168 86 182 81
Not Completed 76 46 73 43
Reason Not Completed
Withdrawal by Subject             33             25             29             19
Lost to Follow-up             19             8             18             15
Physician Decision             6             4             7             2
Death             1             1             2             0
non medical reason             6             2             10             3
Adverse Event             3             4             5             2
Serious Adverse Event             8             2             2             2
Arm/Group Title MTX + Active Etanercept MTX+ Active SSZ +HCQ MTX + Placebo Entaneracept MTX + Placebo SSZ + HCQ(ST) Total
Hide Arm/Group Description Methotrexate (MTX) + etanercept methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) methotrexate (MTX) or MTX + Etanercept methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) Total of all reporting groups
Overall Number of Baseline Participants 244 132 255 124 755
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 132 participants 255 participants 124 participants 755 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
244
 100.0%
132
 100.0%
255
 100.0%
124
 100.0%
755
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 132 participants 255 participants 124 participants 755 participants
50.7  (13.4) 48.8  (12.7) 48.6  (13.0) 49.3  (12.0) 49.4  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 132 participants 255 participants 124 participants 755 participants
Female
181
  74.2%
101
  76.5%
176
  69.0%
87
  70.2%
545
  72.2%
Male
63
  25.8%
31
  23.5%
79
  31.0%
37
  29.8%
210
  27.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 244 participants 132 participants 255 participants 124 participants 755 participants
244 132 255 124 755
1.Primary Outcome
Title Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
Hide Description

Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The ESR is the rate at which red blood cells sediment in a period of one hour.

The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity.

Time Frame Change of the Mean of DAS28-ESR between weeks 48 - 102.
Hide Outcome Measure Data
Hide Analysis Population Description
The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.
Arm/Group Title MTX + Immediate Etanercept MTX+ Immediate SSZ +HCQ MTX + Step-up Etanercept MTX + Step-up SSZ + HCQ(ST)
Hide Arm/Group Description:
Methotrexate (MTX) + etanercept
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
methotrexate (MTX) or MTX + Etanercept
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Overall Number of Participants Analyzed 159 76 166 75
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.0  (1.4) 2.9  (1.5) 3.1  (1.4) 2.8  (1.3)
2.Secondary Outcome
Title Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.
Hide Description Changes in disease progression between treatment groups will be described by the mean score at two years as assessed after adjustment for the baseline radiographic score. Radiographs were observed of hands, wrists, and feet. The range of scores available for the modified Sharp Score is 0 to 448. The erosion score per joint of the hands can range from 0 to 5. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Joint space narrowing and joint subluxation or luxation are combined in a single score with a range of 0 to 4 with a max score of 60. The erosion score per joint can range from 0 to 10, with each side of the joint independently scored from 0 to 5. The maximal erosion score per foot is thus 60. The joint space narrowing and joint (sub)luxation are combined in a single score with a range of 0 to 4. The maximal narrowing/(sub)luxation score per foot is thus 24.
Time Frame Year 2, Week 102
Hide Outcome Measure Data
Hide Analysis Population Description
The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.
Arm/Group Title MTX + Immediate Etanercept MTX+ Immediate SSZ +HCQ MTX + Step-up Etanercept MTX + Step-up SSZ + HCQ(ST)
Hide Arm/Group Description:
Methotrexate (MTX) + etanercept
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
methotrexate (MTX) or MTX + Etanercept
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Overall Number of Participants Analyzed 159 76 166 75
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
7.0  (16.6) 7.3  (13.3) 4.8  (7.2) 6.2  (8.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MTX + Active Etanercept MTX+ Active SSZ +HCQ MTX + Placebo Entaneracept MTX + Placebo SSZ + HCQ(ST)
Hide Arm/Group Description Methotrexate (MTX) + etanercept methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) methotrexate (MTX) or MTX + Etanercept methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
All-Cause Mortality
MTX + Active Etanercept MTX+ Active SSZ +HCQ MTX + Placebo Entaneracept MTX + Placebo SSZ + HCQ(ST)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MTX + Active Etanercept MTX+ Active SSZ +HCQ MTX + Placebo Entaneracept MTX + Placebo SSZ + HCQ(ST)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/244 (14.34%)      18/132 (13.64%)      32/255 (12.55%)      16/124 (12.90%)    
Blood and lymphatic system disorders         
Anemia   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Acute Arterial Thromboembolism   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Dehydration   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Cardiac disorders         
Arterial Blockage   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Congestive Heart Failure   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Chronic obstructive pulmonary disease   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Chest Pain   1/244 (0.41%)  1 1/132 (0.76%)  1 1/255 (0.39%)  1 2/124 (1.61%)  2
Death   0/244 (0.00%)  0 1/132 (0.76%)  1 2/255 (0.78%)  2 0/124 (0.00%)  0
Hypertension   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Left Anterior Descending Stenosis   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Myocardial Infarction   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Eye disorders         
Other Infection   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Gastrointestinal disorders         
Bowel Obstruction   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Dehydration   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Dilated Bowel   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Nausea / Vomiting   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Other Infection   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Perforated Bowel   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
General disorders         
Dehydration   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Syncopal Episode   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Angioedema   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Infections and infestations         
Bronchitis   0/244 (0.00%)  0 2/132 (1.52%)  2 0/255 (0.00%)  0 0/124 (0.00%)  0
Cellulitis   3/244 (1.23%)  3 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Herpes Zoster   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Malaria   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Other Infection   2/244 (0.82%)  2 1/132 (0.76%)  1 2/255 (0.78%)  2 2/124 (1.61%)  2
Pneumonia   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Injury, poisoning and procedural complications         
Fracture   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Injury   2/244 (0.82%)  2 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Investigations         
Elevated LFTs   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
Low Hemoglobin   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Renal Failure   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Metabolism and nutrition disorders         
Diabetes   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 2/124 (1.61%)  2
Musculoskeletal and connective tissue disorders         
Fracture   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Joint Pain   1/244 (0.41%)  1 0/132 (0.00%)  0 3/255 (1.18%)  3 0/124 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer   5/244 (2.05%)  5 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Nervous system disorders         
Cerebellar Infarcation w/ Hydrocephalus   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Chronic Intracranial Hemorrhage   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Headaches   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Neuropathy   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Seizure   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 2/124 (1.61%)  2
Pregnancy, puerperium and perinatal conditions         
Miscarriage   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Pregnancy   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Psychiatric disorders         
Confusion   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Depression   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Psychosis   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Suicidal Ideation   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Reproductive system and breast disorders         
Surgical Procedure   0/244 (0.00%)  0 0/132 (0.00%)  0 3/255 (1.18%)  3 0/124 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
COPD   2/244 (0.82%)  2 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
Cancer   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Chest Pain   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Death   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Other Infection   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Pneumocystis Carini   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Pneumonia   2/244 (0.82%)  2 1/132 (0.76%)  1 3/255 (1.18%)  3 0/124 (0.00%)  0
Pulmonary Fibrosis   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Shortness of Breath   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Surgical and medical procedures         
Cerebral Vascular Accident   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Fracture   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Joint Replacement   3/244 (1.23%)  3 0/132 (0.00%)  0 4/255 (1.57%)  4 0/124 (0.00%)  0
Joint Surgery   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Other Infection   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Perforated Bowel   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Surgical Procedure   1/244 (0.41%)  1 3/132 (2.27%)  3 2/255 (0.78%)  2 1/124 (0.81%)  1
Vascular disorders         
Pulmonary Edema   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Swelling   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Pulmonary embolus   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Transient Ischemic Attack   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
MTX + Active Etanercept MTX+ Active SSZ +HCQ MTX + Placebo Entaneracept MTX + Placebo SSZ + HCQ(ST)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   184/244 (75.41%)      99/132 (75.00%)      180/255 (70.59%)      89/124 (71.77%)    
Blood and lymphatic system disorders         
Anemia   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Edema   8/244 (3.28%)  8 3/132 (2.27%)  3 7/255 (2.75%)  7 2/124 (1.61%)  2
Nose Bleed   2/244 (0.82%)  2 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Purpura   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Cardiac disorders         
Arrhythmia   5/244 (2.05%)  5 1/132 (0.76%)  1 4/255 (1.57%)  4 0/124 (0.00%)  0
Chest Pain   1/244 (0.41%)  1 1/132 (0.76%)  1 3/255 (1.18%)  3 0/124 (0.00%)  0
Congestive heart failure   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
Hypertension   6/244 (2.46%)  6 1/132 (0.76%)  1 4/255 (1.57%)  4 1/124 (0.81%)  1
Hypotension   1/244 (0.41%)  1 2/132 (1.52%)  2 0/255 (0.00%)  0 0/124 (0.00%)  0
PALPITATIONS   1/244 (0.41%)  1 2/132 (1.52%)  2 4/255 (1.57%)  4 1/124 (0.81%)  1
SHORTNESS OF BREATH   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
VENTRICULAR HYPERTROPHY   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Ear and labyrinth disorders         
EAR CONGESTION/FULLNESS   1/244 (0.41%)  1 2/132 (1.52%)  2 2/255 (0.78%)  2 0/124 (0.00%)  0
EARACHE/ INFECTION   1/244 (0.41%)  1 1/132 (0.76%)  1 0/255 (0.00%)  0 2/124 (1.61%)  2
HEARING LOSS   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
TINNITUS   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
Endocrine disorders         
DIABETES   2/244 (0.82%)  2 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
HYPO/HYPERTHYROIDISM   1/244 (0.41%)  1 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
THYROID ENLARGEMENT/NODULES   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
Eye disorders         
CATARACT   0/244 (0.00%)  0 2/132 (1.52%)  2 0/255 (0.00%)  0 1/124 (0.81%)  1
DECREASED VISION   2/244 (0.82%)  2 4/132 (3.03%)  4 6/255 (2.35%)  6 1/124 (0.81%)  1
DRY EYES   0/244 (0.00%)  0 2/132 (1.52%)  2 2/255 (0.78%)  2 0/124 (0.00%)  0
EYE IRRITATION   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
GLAUCOMA   1/244 (0.41%)  1 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
KERATITIS   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
MELANOSIS   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
OTHER SURGERY/PROCEDURE   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
PARACENTRAL DEPRESSIONS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
PHOTOPHOBIA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
SJORGRENS SYNDROME   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
SUBCONJUNCTIVAL HEMORRHAGE   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
XANTHELASMA   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Gastrointestinal disorders         
ABDOMINAL CRAMPS/PAIN   8/244 (3.28%)  8 1/132 (0.76%)  1 11/255 (4.31%)  11 5/124 (4.03%)  5
ALTERED TASTE   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
BLACK STOOLS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
CONSTIPATION   6/244 (2.46%)  6 3/132 (2.27%)  3 5/255 (1.96%)  5 3/124 (2.42%)  3
DIARRHEA/LOOSE STOOLS   8/244 (3.28%)  8 6/132 (4.55%)  6 5/255 (1.96%)  5 8/124 (6.45%)  8
DIVERTICULITIS   2/244 (0.82%)  2 1/132 (0.76%)  1 1/255 (0.39%)  1 0/124 (0.00%)  0
DYSPHAGIA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
FLATULENCE   0/244 (0.00%)  0 1/132 (0.76%)  1 1/255 (0.39%)  1 1/124 (0.81%)  1
GERD   17/244 (6.97%)  17 2/132 (1.52%)  2 11/255 (4.31%)  11 5/124 (4.03%)  5
GI FLU   13/244 (5.33%)  13 9/132 (6.82%)  9 12/255 (4.71%)  12 4/124 (3.23%)  4
GI ULCER   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
HEMORRHOIDS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
INFLAMMATORY BOWEL DISEASE   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
NAUSEA/VOMITING   11/244 (4.51%)  11 12/132 (9.09%)  12 11/255 (4.31%)  11 6/124 (4.84%)  6
OCCLUDED/SWOLLEN SALIVARY GLAND   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
ORAL ULCERS   0/244 (0.00%)  0 1/132 (0.76%)  1 2/255 (0.78%)  2 1/124 (0.81%)  1
OTHER INFECTION   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
RECTAL BLEEDING   0/244 (0.00%)  0 1/132 (0.76%)  1 1/255 (0.39%)  1 0/124 (0.00%)  0
Other   3/244 (1.23%)  3 0/132 (0.00%)  0 0/255 (0.00%)  0 2/124 (1.61%)  2
General disorders         
ALOPECIA   0/244 (0.00%)  0 1/132 (0.76%)  1 6/255 (2.35%)  6 0/124 (0.00%)  0
ALTERED TASTE   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
BURNING SENSATION   1/244 (0.41%)  1 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
CHILLS/SWEATS   2/244 (0.82%)  2 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
DENTAL PAIN/INFECTION/ABSCESS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
DRY MOUTH   3/244 (1.23%)  3 1/132 (0.76%)  1 1/255 (0.39%)  1 0/124 (0.00%)  0
FATIGUE   5/244 (2.05%)  5 8/132 (6.06%)  8 7/255 (2.75%)  7 3/124 (2.42%)  3
HOARSENESS OF VOICE   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
HOT FLASHES   2/244 (0.82%)  2 0/132 (0.00%)  0 4/255 (1.57%)  4 2/124 (1.61%)  2
INJECTION SITE REACTION   2/244 (0.82%)  2 3/132 (2.27%)  3 9/255 (3.53%)  9 0/124 (0.00%)  0
INJURY   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
INSOMINA   2/244 (0.82%)  2 1/132 (0.76%)  1 2/255 (0.78%)  2 0/124 (0.00%)  0
INSOMNIA   2/244 (0.82%)  2 3/132 (2.27%)  3 2/255 (0.78%)  2 1/124 (0.81%)  1
SLEEP APNEA   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
SORE TONGUE   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
SYNCOPY   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
TONGUE FISSURES   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
VOICE HOARSENESS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Hepatobiliary disorders         
CHOLECYSTITIS/CHOLELITHIASIS   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
FATTY LIVER   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
HEPATOMEGALY   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Immune system disorders         
ALLERGIC REACTION   10/244 (4.10%)  10 2/132 (1.52%)  2 6/255 (2.35%)  6 2/124 (1.61%)  2
SEASONAL ALLERGY   1/244 (0.41%)  1 1/132 (0.76%)  1 4/255 (1.57%)  4 1/124 (0.81%)  1
Infections and infestations         
CANDIDIASIS   3/244 (1.23%)  3 1/132 (0.76%)  1 2/255 (0.78%)  2 0/124 (0.00%)  0
COMMON COLD   7/244 (2.87%)  7 2/132 (1.52%)  2 1/255 (0.39%)  1 1/124 (0.81%)  1
COUGH   7/244 (2.87%)  7 0/132 (0.00%)  0 5/255 (1.96%)  5 4/124 (3.23%)  4
DENTAL PAIN/INFECTION/ABSCESS   6/244 (2.46%)  6 2/132 (1.52%)  2 14/255 (5.49%)  14 9/124 (7.26%)  9
DERMATALOGIC ERUPTION   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
EARACHE/ INFECTION   12/244 (4.92%)  12 7/132 (5.30%)  7 5/255 (1.96%)  5 1/124 (0.81%)  1
EYE INFECTION   5/244 (2.05%)  5 0/132 (0.00%)  0 5/255 (1.96%)  5 1/124 (0.81%)  1
Fever   0/244 (0.00%)  0 1/132 (0.76%)  1 3/255 (1.18%)  3 1/124 (0.81%)  1
FLU /FLU LIKE SYMPTOMS   2/244 (0.82%)  2 2/132 (1.52%)  2 4/255 (1.57%)  4 2/124 (1.61%)  2
HERPES   5/244 (2.05%)  5 5/132 (3.79%)  5 7/255 (2.75%)  7 1/124 (0.81%)  1
INFECTED FINGER   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
INFECTED TOENAIL   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
LYMPHADENOPATHY/LYMPHADENITIS   1/244 (0.41%)  1 2/132 (1.52%)  2 3/255 (1.18%)  3 0/124 (0.00%)  0
OTHER INFECTION   15/244 (6.15%)  15 7/132 (5.30%)  7 12/255 (4.71%)  12 9/124 (7.26%)  9
PHARYNGITIS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Pneumonia   1/244 (0.41%)  1 2/132 (1.52%)  2 0/255 (0.00%)  0 0/124 (0.00%)  0
PROSTATE INFECTION/ENLARGEMENT   1/244 (0.41%)  1 2/132 (1.52%)  2 0/255 (0.00%)  0 0/124 (0.00%)  0
SINUS INFECTION   21/244 (8.61%)  21 13/132 (9.85%)  13 19/255 (7.45%)  19 11/124 (8.87%)  11
SORE THROAT   2/244 (0.82%)  2 0/132 (0.00%)  0 3/255 (1.18%)  3 2/124 (1.61%)  2
STREP THROAT   3/244 (1.23%)  3 1/132 (0.76%)  1 1/255 (0.39%)  1 1/124 (0.81%)  1
Upper respiratory tract infection   131/244 (53.69%)  131 67/132 (50.76%)  67 146/255 (57.25%)  146 5/124 (4.03%)  5
Urinary Tract Infection   19/244 (7.79%)  19 6/132 (4.55%)  6 29/255 (11.37%)  29 8/124 (6.45%)  8
Vaginal/Pelvic Infection   6/244 (2.46%)  6 5/132 (3.79%)  5 3/255 (1.18%)  3 2/124 (1.61%)  2
Weight gain   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Injury, poisoning and procedural complications         
Burn   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
DERMATALOGIC ERUPTION   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
EXTREMITY SPRAIN/CRAMPS   1/244 (0.41%)  1 0/132 (0.00%)  0 4/255 (1.57%)  4 0/124 (0.00%)  0
FRACTURE   5/244 (2.05%)  5 5/132 (3.79%)  5 1/255 (0.39%)  1 2/124 (1.61%)  2
INJURY   9/244 (3.69%)  9 4/132 (3.03%)  4 12/255 (4.71%)  12 11/124 (8.87%)  11
Joint Pain   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
Other   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Investigations         
anemia   3/244 (1.23%)  3 4/132 (3.03%)  4 4/255 (1.57%)  4 2/124 (1.61%)  2
ELEVATED CK AND ALDOLASE   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
ELEVATED CREATININE   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
ELEVATED LIVER ENZYMES   14/244 (5.74%)  14 1/132 (0.76%)  1 17/255 (6.67%)  17 5/124 (4.03%)  5
HYPERCHOLESTEROLEMIA   1/244 (0.41%)  1 0/132 (0.00%)  0 3/255 (1.18%)  3 1/124 (0.81%)  1
HYPERGLYCEMIA   3/244 (1.23%)  3 1/132 (0.76%)  1 1/255 (0.39%)  1 0/124 (0.00%)  0
HYPERKALEMIA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
INCREASED ESR   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
LABORATORY ERROR   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
LEUKOCYTOSIS/LEUKOPENIA   5/244 (2.05%)  5 4/132 (3.03%)  4 2/255 (0.78%)  2 2/124 (1.61%)  2
OTHER SURGERY/PROCEDURE   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
THROMBOCYTOSIS/THROMBOCYTOPENIA   2/244 (0.82%)  2 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Metabolism and nutrition disorders         
VITAMIN B-12 DEFICIENCY   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Musculoskeletal and connective tissue disorders         
CHEST PAIN   2/244 (0.82%)  2 1/132 (0.76%)  1 5/255 (1.96%)  5 3/124 (2.42%)  3
EXTREMITY SPRAIN/CRAMPS   13/244 (5.33%)  13 7/132 (5.30%)  7 17/255 (6.67%)  17 4/124 (3.23%)  4
FIBROMYALGIA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
FRACTURE   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
GOUT   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
HEALED FRACTURE   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
HERNIA   2/244 (0.82%)  2 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Joint Pain   66/244 (27.05%)  66 23/132 (17.42%)  23 57/255 (22.35%)  57 22/124 (17.74%)  22
Joint Surgery/Procedure   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
Mixed Connective Tissue Disease   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 2/124 (1.61%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
DERMATALOGIC ERUPTION   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
LUMP/NODULE   7/244 (2.87%)  7 2/132 (1.52%)  2 9/255 (3.53%)  9 1/124 (0.81%)  1
LUNG CANCER   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
RENAL CARCINOMA   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
SKIN CANCER   2/244 (0.82%)  2 3/132 (2.27%)  3 3/255 (1.18%)  3 1/124 (0.81%)  1
SUBUNGUAL NEVUS   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
THYROID ENLARGEMENT/NODULES   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
Nervous system disorders         
CHARCOT MARIE SYNDROME   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
DIZZINESS   7/244 (2.87%)  7 3/132 (2.27%)  3 8/255 (3.14%)  8 2/124 (1.61%)  2
FACIAL DROOP   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
HEADACHE   14/244 (5.74%)  14 8/132 (6.06%)  8 25/255 (9.80%)  25 6/124 (4.84%)  6
MEMORY LOSS/CONFUSION   0/244 (0.00%)  0 1/132 (0.76%)  1 2/255 (0.78%)  2 0/124 (0.00%)  0
NEUROMA   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
NEUROPATHY   6/244 (2.46%)  6 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
NUMBNESS, DROOPING   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
SEIZURE   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
SYNCOPY   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
TREMORS   3/244 (1.23%)  3 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Psychiatric disorders         
ANXIETY/NERVOUSNESS/IRRITABILITY   0/244 (0.00%)  0 4/132 (3.03%)  4 4/255 (1.57%)  4 1/124 (0.81%)  1
BIPOLAR DISORDER   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 2/124 (1.61%)  2
DEPRESSION   3/244 (1.23%)  3 4/132 (3.03%)  4 6/255 (2.35%)  6 3/124 (2.42%)  3
METHADONE WITHDRAWAL   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Renal and urinary disorders         
DYSURIA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
HEMATURIA   3/244 (1.23%)  3 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
NOCTURIA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
RENAL CALCULI   2/244 (0.82%)  2 0/132 (0.00%)  0 3/255 (1.18%)  3 1/124 (0.81%)  1
URINARY INCONTINENCE/FREQUENCY/URGENCY   2/244 (0.82%)  2 1/132 (0.76%)  1 3/255 (1.18%)  3 1/124 (0.81%)  1
Reproductive system and breast disorders         
ABNORMAL MENSES   0/244 (0.00%)  0 0/132 (0.00%)  0 2/255 (0.78%)  2 0/124 (0.00%)  0
ATYPICAL PAP TEST   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 3/124 (2.42%)  3
PROLAPSED UTERUS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
PROSTATE INFECTION/ENLARGEMENT   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
VAGINAL DISCHARGE/BLEEDING   0/244 (0.00%)  0 2/132 (1.52%)  2 4/255 (1.57%)  4 3/124 (2.42%)  3
VAGINAL DRYNESS   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
ASTHMA/COPD   4/244 (1.64%)  4 0/132 (0.00%)  0 3/255 (1.18%)  3 3/124 (2.42%)  3
CHEST PAIN   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
NOSE BLEED   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
PLEURAL EFFUSION   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
SHORTNESS OF BREATH   4/244 (1.64%)  4 0/132 (0.00%)  0 5/255 (1.96%)  5 0/124 (0.00%)  0
TRACHEAL STENOSIS   2/244 (0.82%)  2 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Skin and subcutaneous tissue disorders         
BRITTLE FINGERNAILS   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
CHILLS/SWEATS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
DELAYED WOUND HEALING   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 2/124 (1.61%)  2
DERMATALOGIC ERUPTION   36/244 (14.75%)  36 16/132 (12.12%)  16 37/255 (14.51%)  37 14/124 (11.29%)  14
INJURY   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
MELASMA   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
NASAL IRRITATION/EROSION   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
ORAL ULCERS   0/244 (0.00%)  0 1/132 (0.76%)  1 2/255 (0.78%)  2 5/124 (4.03%)  5
OTHER   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
OTHER INFECTION   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
PEELING SKIN   0/244 (0.00%)  0 1/132 (0.76%)  1 0/255 (0.00%)  0 0/124 (0.00%)  0
PETECHIA   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
PLANTAR FASCITIS   1/244 (0.41%)  1 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
POOR WOUND HEALING   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
SUPRACLAVICULAR FAT PADS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
Surgical and medical procedures         
CATARACT   9/244 (3.69%)  9 0/132 (0.00%)  0 0/255 (0.00%)  0 1/124 (0.81%)  1
DENTAL PAIN/INFECTION/ABSCESS   2/244 (0.82%)  2 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
DERMATALOGIC ERUPTION   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 1/124 (0.81%)  1
FRACTURE   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
INJURY   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
JOINT SURGERY/PROCEDURE   1/244 (0.41%)  1 0/132 (0.00%)  0 4/255 (1.57%)  4 1/124 (0.81%)  1
OTHER SURGERY/PROCEDURE   1/244 (0.41%)  1 2/132 (1.52%)  2 9/255 (3.53%)  9 8/124 (6.45%)  8
Vascular disorders         
CLAUDICATION   0/244 (0.00%)  0 0/132 (0.00%)  0 0/255 (0.00%)  0 2/124 (1.61%)  2
DEEP VEIN THROMBOSIS   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
NOSE BLEED   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
PERIPHERAL VASCULAR DISEASE   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
THROMBOPHLEBITIS   0/244 (0.00%)  0 0/132 (0.00%)  0 1/255 (0.39%)  1 0/124 (0.00%)  0
VARICOSE VEIN   1/244 (0.41%)  1 0/132 (0.00%)  0 0/255 (0.00%)  0 0/124 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jeffrey R. Curtis,
Organization: University of Alabama at Birmingham
Phone: 205-934-7733
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00259610     History of Changes
Other Study ID Numbers: X031030004
20040391
First Submitted: November 28, 2005
First Posted: November 29, 2005
Results First Submitted: May 31, 2012
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014