Trial Outcomes & Findings for Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) (NCT NCT00259610)
NCT ID: NCT00259610
Last Updated: 2014-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
755 participants
Primary outcome timeframe
Change of the Mean of DAS28-ESR between weeks 48 - 102.
Results posted on
2014-07-17
Participant Flow
Recruitment began in May 2004 and concluded in January 2007.
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.
Participant milestones
| Measure |
MTX + Active Etanercept
Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
|
MTX+ Active SSZ +HCQ
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
|
MTX + Placebo Entaneracept
Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
|
MTX + Placebo SSZ + HCQ(ST)
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
244
|
132
|
255
|
124
|
|
Overall Study
COMPLETED
|
168
|
86
|
182
|
81
|
|
Overall Study
NOT COMPLETED
|
76
|
46
|
73
|
43
|
Reasons for withdrawal
| Measure |
MTX + Active Etanercept
Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
|
MTX+ Active SSZ +HCQ
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
|
MTX + Placebo Entaneracept
Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
|
MTX + Placebo SSZ + HCQ(ST)
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
33
|
25
|
29
|
19
|
|
Overall Study
Lost to Follow-up
|
19
|
8
|
18
|
15
|
|
Overall Study
Physician Decision
|
6
|
4
|
7
|
2
|
|
Overall Study
Death
|
1
|
1
|
2
|
0
|
|
Overall Study
non medical reason
|
6
|
2
|
10
|
3
|
|
Overall Study
Adverse Event
|
3
|
4
|
5
|
2
|
|
Overall Study
Serious Adverse Event
|
8
|
2
|
2
|
2
|
Baseline Characteristics
Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
Baseline characteristics by cohort
| Measure |
MTX + Active Etanercept
n=244 Participants
Methotrexate (MTX) + etanercept
|
MTX+ Active SSZ +HCQ
n=132 Participants
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
MTX + Placebo Entaneracept
n=255 Participants
methotrexate (MTX) or MTX + Etanercept
|
MTX + Placebo SSZ + HCQ(ST)
n=124 Participants
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
Total
n=755 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
|
|
Age, Categorical
Between 18 and 65 years
|
244 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
755 Participants
n=21 Participants
|
|
Age, Categorical
>=65 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
|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
545 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
244 participants
n=5 Participants
|
132 participants
n=7 Participants
|
255 participants
n=5 Participants
|
124 participants
n=4 Participants
|
755 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change of the Mean of DAS28-ESR between weeks 48 - 102.Population: The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.
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.
Outcome measures
| Measure |
MTX + Immediate Etanercept
n=159 Participants
Methotrexate (MTX) + etanercept
|
MTX+ Immediate SSZ +HCQ
n=76 Participants
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
MTX + Step-up Etanercept
n=166 Participants
methotrexate (MTX) or MTX + Etanercept
|
MTX + Step-up SSZ + HCQ(ST)
n=75 Participants
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
|---|---|---|---|---|
|
Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
|
3.0 Scores on a scale
Standard Deviation 1.4
|
2.9 Scores on a scale
Standard Deviation 1.5
|
3.1 Scores on a scale
Standard Deviation 1.4
|
2.8 Scores on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Year 2, Week 102Population: The participants that were randomized into this clinical trial and completed the study to year 2, represent the number for analysis.
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.
Outcome measures
| Measure |
MTX + Immediate Etanercept
n=159 Participants
Methotrexate (MTX) + etanercept
|
MTX+ Immediate SSZ +HCQ
n=76 Participants
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
MTX + Step-up Etanercept
n=166 Participants
methotrexate (MTX) or MTX + Etanercept
|
MTX + Step-up SSZ + HCQ(ST)
n=75 Participants
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
|---|---|---|---|---|
|
Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.
|
7.0 Scores on a scale
Standard Deviation 16.6
|
7.3 Scores on a scale
Standard Deviation 13.3
|
4.8 Scores on a scale
Standard Deviation 7.2
|
6.2 Scores on a scale
Standard Deviation 8.9
|
Adverse Events
MTX + Active Etanercept
Serious events: 35 serious events
Other events: 184 other events
Deaths: 0 deaths
MTX+ Active SSZ +HCQ
Serious events: 18 serious events
Other events: 99 other events
Deaths: 0 deaths
MTX + Placebo Entaneracept
Serious events: 32 serious events
Other events: 180 other events
Deaths: 0 deaths
MTX + Placebo SSZ + HCQ(ST)
Serious events: 16 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MTX + Active Etanercept
n=244 participants at risk
Methotrexate (MTX) + etanercept
|
MTX+ Active SSZ +HCQ
n=132 participants at risk
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
MTX + Placebo Entaneracept
n=255 participants at risk
methotrexate (MTX) or MTX + Etanercept
|
MTX + Placebo SSZ + HCQ(ST)
n=124 participants at risk
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Blood and lymphatic system disorders
Acute Arterial Thromboembolism
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Blood and lymphatic system disorders
Dehydration
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Cardiac disorders
Arterial Blockage
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Cardiac disorders
Congestive Heart Failure
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Cardiac disorders
Chronic obstructive pulmonary disease
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
0.41%
1/244 • Number of events 1
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
1.6%
2/124 • Number of events 2
|
|
Cardiac disorders
Death
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Cardiac disorders
Hypertension
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Cardiac disorders
Left Anterior Descending Stenosis
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Eye disorders
Other Infection
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
Dehydration
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
Dilated Bowel
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
Nausea / Vomiting
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
Other Infection
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
Perforated Bowel
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
General disorders
Dehydration
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
Syncopal Episode
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
Angioedema
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
Bronchitis
|
0.00%
0/244
|
1.5%
2/132 • Number of events 2
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
Cellulitis
|
1.2%
3/244 • Number of events 3
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Infections and infestations
Malaria
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
Other Infection
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
1.6%
2/124 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Investigations
Elevated LFTs
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Investigations
Low Hemoglobin
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Investigations
Renal Failure
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
1.2%
3/255 • Number of events 3
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.0%
5/244 • Number of events 5
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Nervous system disorders
Cerebellar Infarcation w/ Hydrocephalus
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Nervous system disorders
Chronic Intracranial Hemorrhage
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Nervous system disorders
Headaches
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Nervous system disorders
Seizure
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Psychiatric disorders
Confusion
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Psychiatric disorders
Depression
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Psychiatric disorders
Suicidal Ideation
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Reproductive system and breast disorders
Surgical Procedure
|
0.00%
0/244
|
0.00%
0/132
|
1.2%
3/255 • Number of events 3
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cancer
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Other Infection
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Pneumocystis Carini
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
1.2%
3/255 • Number of events 3
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Surgical and medical procedures
Cerebral Vascular Accident
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Surgical and medical procedures
Fracture
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Surgical and medical procedures
Joint Replacement
|
1.2%
3/244 • Number of events 3
|
0.00%
0/132
|
1.6%
4/255 • Number of events 4
|
0.00%
0/124
|
|
Surgical and medical procedures
Joint Surgery
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Surgical and medical procedures
Other Infection
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Surgical and medical procedures
Perforated Bowel
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Surgical and medical procedures
Surgical Procedure
|
0.41%
1/244 • Number of events 1
|
2.3%
3/132 • Number of events 3
|
0.78%
2/255 • Number of events 2
|
0.81%
1/124 • Number of events 1
|
|
Vascular disorders
Pulmonary Edema
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Vascular disorders
Swelling
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Vascular disorders
Pulmonary embolus
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Vascular disorders
Transient Ischemic Attack
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
Other adverse events
| Measure |
MTX + Active Etanercept
n=244 participants at risk
Methotrexate (MTX) + etanercept
|
MTX+ Active SSZ +HCQ
n=132 participants at risk
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
MTX + Placebo Entaneracept
n=255 participants at risk
methotrexate (MTX) or MTX + Etanercept
|
MTX + Placebo SSZ + HCQ(ST)
n=124 participants at risk
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Blood and lymphatic system disorders
Edema
|
3.3%
8/244 • Number of events 8
|
2.3%
3/132 • Number of events 3
|
2.7%
7/255 • Number of events 7
|
1.6%
2/124 • Number of events 2
|
|
Blood and lymphatic system disorders
Nose Bleed
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Blood and lymphatic system disorders
Purpura
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Cardiac disorders
Arrhythmia
|
2.0%
5/244 • Number of events 5
|
0.76%
1/132 • Number of events 1
|
1.6%
4/255 • Number of events 4
|
0.00%
0/124
|
|
Cardiac disorders
Chest Pain
|
0.41%
1/244 • Number of events 1
|
0.76%
1/132 • Number of events 1
|
1.2%
3/255 • Number of events 3
|
0.00%
0/124
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Cardiac disorders
Hypertension
|
2.5%
6/244 • Number of events 6
|
0.76%
1/132 • Number of events 1
|
1.6%
4/255 • Number of events 4
|
0.81%
1/124 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
0.00%
0/255
|
0.00%
0/124
|
|
Cardiac disorders
PALPITATIONS
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
1.6%
4/255 • Number of events 4
|
0.81%
1/124 • Number of events 1
|
|
Cardiac disorders
SHORTNESS OF BREATH
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Cardiac disorders
VENTRICULAR HYPERTROPHY
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Ear and labyrinth disorders
EAR CONGESTION/FULLNESS
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Ear and labyrinth disorders
EARACHE/ INFECTION
|
0.41%
1/244 • Number of events 1
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Ear and labyrinth disorders
HEARING LOSS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Ear and labyrinth disorders
TINNITUS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Endocrine disorders
DIABETES
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Endocrine disorders
HYPO/HYPERTHYROIDISM
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Endocrine disorders
THYROID ENLARGEMENT/NODULES
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Eye disorders
CATARACT
|
0.00%
0/244
|
1.5%
2/132 • Number of events 2
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Eye disorders
DECREASED VISION
|
0.82%
2/244 • Number of events 2
|
3.0%
4/132 • Number of events 4
|
2.4%
6/255 • Number of events 6
|
0.81%
1/124 • Number of events 1
|
|
Eye disorders
DRY EYES
|
0.00%
0/244
|
1.5%
2/132 • Number of events 2
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Eye disorders
EYE IRRITATION
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Eye disorders
GLAUCOMA
|
0.41%
1/244 • Number of events 1
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Eye disorders
KERATITIS
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Eye disorders
MELANOSIS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Eye disorders
OTHER SURGERY/PROCEDURE
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Eye disorders
PARACENTRAL DEPRESSIONS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Eye disorders
SJORGRENS SYNDROME
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Eye disorders
SUBCONJUNCTIVAL HEMORRHAGE
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Eye disorders
XANTHELASMA
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
ABDOMINAL CRAMPS/PAIN
|
3.3%
8/244 • Number of events 8
|
0.76%
1/132 • Number of events 1
|
4.3%
11/255 • Number of events 11
|
4.0%
5/124 • Number of events 5
|
|
Gastrointestinal disorders
ALTERED TASTE
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
BLACK STOOLS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.5%
6/244 • Number of events 6
|
2.3%
3/132 • Number of events 3
|
2.0%
5/255 • Number of events 5
|
2.4%
3/124 • Number of events 3
|
|
Gastrointestinal disorders
DIARRHEA/LOOSE STOOLS
|
3.3%
8/244 • Number of events 8
|
4.5%
6/132 • Number of events 6
|
2.0%
5/255 • Number of events 5
|
6.5%
8/124 • Number of events 8
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Gastrointestinal disorders
GERD
|
7.0%
17/244 • Number of events 17
|
1.5%
2/132 • Number of events 2
|
4.3%
11/255 • Number of events 11
|
4.0%
5/124 • Number of events 5
|
|
Gastrointestinal disorders
GI FLU
|
5.3%
13/244 • Number of events 13
|
6.8%
9/132 • Number of events 9
|
4.7%
12/255 • Number of events 12
|
3.2%
4/124 • Number of events 4
|
|
Gastrointestinal disorders
GI ULCER
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Gastrointestinal disorders
INFLAMMATORY BOWEL DISEASE
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA/VOMITING
|
4.5%
11/244 • Number of events 11
|
9.1%
12/132 • Number of events 12
|
4.3%
11/255 • Number of events 11
|
4.8%
6/124 • Number of events 6
|
|
Gastrointestinal disorders
OCCLUDED/SWOLLEN SALIVARY GLAND
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Gastrointestinal disorders
ORAL ULCERS
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
0.81%
1/124 • Number of events 1
|
|
Gastrointestinal disorders
OTHER INFECTION
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Gastrointestinal disorders
RECTAL BLEEDING
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
ALOPECIA
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
2.4%
6/255 • Number of events 6
|
0.00%
0/124
|
|
General disorders
ALTERED TASTE
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
General disorders
BURNING SENSATION
|
0.41%
1/244 • Number of events 1
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
General disorders
CHILLS/SWEATS
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
DENTAL PAIN/INFECTION/ABSCESS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
DRY MOUTH
|
1.2%
3/244 • Number of events 3
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
FATIGUE
|
2.0%
5/244 • Number of events 5
|
6.1%
8/132 • Number of events 8
|
2.7%
7/255 • Number of events 7
|
2.4%
3/124 • Number of events 3
|
|
General disorders
HOARSENESS OF VOICE
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
General disorders
HOT FLASHES
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
1.6%
4/255 • Number of events 4
|
1.6%
2/124 • Number of events 2
|
|
General disorders
INJECTION SITE REACTION
|
0.82%
2/244 • Number of events 2
|
2.3%
3/132 • Number of events 3
|
3.5%
9/255 • Number of events 9
|
0.00%
0/124
|
|
General disorders
INJURY
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
INSOMINA
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
General disorders
INSOMNIA
|
0.82%
2/244 • Number of events 2
|
2.3%
3/132 • Number of events 3
|
0.78%
2/255 • Number of events 2
|
0.81%
1/124 • Number of events 1
|
|
Gastrointestinal disorders
Other
|
1.2%
3/244 • Number of events 3
|
0.00%
0/132
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
General disorders
SLEEP APNEA
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
General disorders
SORE TONGUE
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
SYNCOPY
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
General disorders
TONGUE FISSURES
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
General disorders
VOICE HOARSENESS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Hepatobiliary disorders
CHOLECYSTITIS/CHOLELITHIASIS
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Hepatobiliary disorders
FATTY LIVER
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Immune system disorders
ALLERGIC REACTION
|
4.1%
10/244 • Number of events 10
|
1.5%
2/132 • Number of events 2
|
2.4%
6/255 • Number of events 6
|
1.6%
2/124 • Number of events 2
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.41%
1/244 • Number of events 1
|
0.76%
1/132 • Number of events 1
|
1.6%
4/255 • Number of events 4
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
CANDIDIASIS
|
1.2%
3/244 • Number of events 3
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Infections and infestations
COMMON COLD
|
2.9%
7/244 • Number of events 7
|
1.5%
2/132 • Number of events 2
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
COUGH
|
2.9%
7/244 • Number of events 7
|
0.00%
0/132
|
2.0%
5/255 • Number of events 5
|
3.2%
4/124 • Number of events 4
|
|
Infections and infestations
DENTAL PAIN/INFECTION/ABSCESS
|
2.5%
6/244 • Number of events 6
|
1.5%
2/132 • Number of events 2
|
5.5%
14/255 • Number of events 14
|
7.3%
9/124 • Number of events 9
|
|
Infections and infestations
DERMATALOGIC ERUPTION
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
EARACHE/ INFECTION
|
4.9%
12/244 • Number of events 12
|
5.3%
7/132 • Number of events 7
|
2.0%
5/255 • Number of events 5
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
EYE INFECTION
|
2.0%
5/244 • Number of events 5
|
0.00%
0/132
|
2.0%
5/255 • Number of events 5
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
Fever
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
1.2%
3/255 • Number of events 3
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
FLU /FLU LIKE SYMPTOMS
|
0.82%
2/244 • Number of events 2
|
1.5%
2/132 • Number of events 2
|
1.6%
4/255 • Number of events 4
|
1.6%
2/124 • Number of events 2
|
|
Infections and infestations
HERPES
|
2.0%
5/244 • Number of events 5
|
3.8%
5/132 • Number of events 5
|
2.7%
7/255 • Number of events 7
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
INFECTED FINGER
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Infections and infestations
INFECTED TOENAIL
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
LYMPHADENOPATHY/LYMPHADENITIS
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
1.2%
3/255 • Number of events 3
|
0.00%
0/124
|
|
Infections and infestations
OTHER INFECTION
|
6.1%
15/244 • Number of events 15
|
5.3%
7/132 • Number of events 7
|
4.7%
12/255 • Number of events 12
|
7.3%
9/124 • Number of events 9
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Infections and infestations
Pneumonia
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
PROSTATE INFECTION/ENLARGEMENT
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
0.00%
0/255
|
0.00%
0/124
|
|
Infections and infestations
SINUS INFECTION
|
8.6%
21/244 • Number of events 21
|
9.8%
13/132 • Number of events 13
|
7.5%
19/255 • Number of events 19
|
8.9%
11/124 • Number of events 11
|
|
Infections and infestations
SORE THROAT
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
1.2%
3/255 • Number of events 3
|
1.6%
2/124 • Number of events 2
|
|
Infections and infestations
STREP THROAT
|
1.2%
3/244 • Number of events 3
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
53.7%
131/244 • Number of events 131
|
50.8%
67/132 • Number of events 67
|
57.3%
146/255 • Number of events 146
|
4.0%
5/124 • Number of events 5
|
|
Infections and infestations
Urinary Tract Infection
|
7.8%
19/244 • Number of events 19
|
4.5%
6/132 • Number of events 6
|
11.4%
29/255 • Number of events 29
|
6.5%
8/124 • Number of events 8
|
|
Infections and infestations
Vaginal/Pelvic Infection
|
2.5%
6/244 • Number of events 6
|
3.8%
5/132 • Number of events 5
|
1.2%
3/255 • Number of events 3
|
1.6%
2/124 • Number of events 2
|
|
Infections and infestations
Weight gain
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Burn
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
DERMATALOGIC ERUPTION
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
EXTREMITY SPRAIN/CRAMPS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
1.6%
4/255 • Number of events 4
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
FRACTURE
|
2.0%
5/244 • Number of events 5
|
3.8%
5/132 • Number of events 5
|
0.39%
1/255 • Number of events 1
|
1.6%
2/124 • Number of events 2
|
|
Injury, poisoning and procedural complications
INJURY
|
3.7%
9/244 • Number of events 9
|
3.0%
4/132 • Number of events 4
|
4.7%
12/255 • Number of events 12
|
8.9%
11/124 • Number of events 11
|
|
Injury, poisoning and procedural complications
Joint Pain
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Injury, poisoning and procedural complications
Other
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Investigations
anemia
|
1.2%
3/244 • Number of events 3
|
3.0%
4/132 • Number of events 4
|
1.6%
4/255 • Number of events 4
|
1.6%
2/124 • Number of events 2
|
|
Investigations
ELEVATED CK AND ALDOLASE
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Investigations
ELEVATED CREATININE
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Investigations
ELEVATED LIVER ENZYMES
|
5.7%
14/244 • Number of events 14
|
0.76%
1/132 • Number of events 1
|
6.7%
17/255 • Number of events 17
|
4.0%
5/124 • Number of events 5
|
|
Investigations
HYPERCHOLESTEROLEMIA
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
1.2%
3/255 • Number of events 3
|
0.81%
1/124 • Number of events 1
|
|
Investigations
HYPERGLYCEMIA
|
1.2%
3/244 • Number of events 3
|
0.76%
1/132 • Number of events 1
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Investigations
HYPERKALEMIA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Investigations
INCREASED ESR
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Investigations
LABORATORY ERROR
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Investigations
LEUKOCYTOSIS/LEUKOPENIA
|
2.0%
5/244 • Number of events 5
|
3.0%
4/132 • Number of events 4
|
0.78%
2/255 • Number of events 2
|
1.6%
2/124 • Number of events 2
|
|
Investigations
OTHER SURGERY/PROCEDURE
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Investigations
THROMBOCYTOSIS/THROMBOCYTOPENIA
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
VITAMIN B-12 DEFICIENCY
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
CHEST PAIN
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
2.0%
5/255 • Number of events 5
|
2.4%
3/124 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY SPRAIN/CRAMPS
|
5.3%
13/244 • Number of events 13
|
5.3%
7/132 • Number of events 7
|
6.7%
17/255 • Number of events 17
|
3.2%
4/124 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
GOUT
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
HEALED FRACTURE
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
HERNIA
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
27.0%
66/244 • Number of events 66
|
17.4%
23/132 • Number of events 23
|
22.4%
57/255 • Number of events 57
|
17.7%
22/124 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Joint Surgery/Procedure
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Mixed Connective Tissue Disease
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DERMATALOGIC ERUPTION
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUMP/NODULE
|
2.9%
7/244 • Number of events 7
|
1.5%
2/132 • Number of events 2
|
3.5%
9/255 • Number of events 9
|
0.81%
1/124 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CARCINOMA
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.82%
2/244 • Number of events 2
|
2.3%
3/132 • Number of events 3
|
1.2%
3/255 • Number of events 3
|
0.81%
1/124 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SUBUNGUAL NEVUS
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID ENLARGEMENT/NODULES
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Nervous system disorders
CHARCOT MARIE SYNDROME
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Nervous system disorders
DIZZINESS
|
2.9%
7/244 • Number of events 7
|
2.3%
3/132 • Number of events 3
|
3.1%
8/255 • Number of events 8
|
1.6%
2/124 • Number of events 2
|
|
Nervous system disorders
FACIAL DROOP
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
5.7%
14/244 • Number of events 14
|
6.1%
8/132 • Number of events 8
|
9.8%
25/255 • Number of events 25
|
4.8%
6/124 • Number of events 6
|
|
Nervous system disorders
MEMORY LOSS/CONFUSION
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Nervous system disorders
NEUROMA
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Nervous system disorders
NEUROPATHY
|
2.5%
6/244 • Number of events 6
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Nervous system disorders
NUMBNESS, DROOPING
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Nervous system disorders
SEIZURE
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Nervous system disorders
SYNCOPY
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Nervous system disorders
TREMORS
|
1.2%
3/244 • Number of events 3
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Psychiatric disorders
ANXIETY/NERVOUSNESS/IRRITABILITY
|
0.00%
0/244
|
3.0%
4/132 • Number of events 4
|
1.6%
4/255 • Number of events 4
|
0.81%
1/124 • Number of events 1
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Psychiatric disorders
DEPRESSION
|
1.2%
3/244 • Number of events 3
|
3.0%
4/132 • Number of events 4
|
2.4%
6/255 • Number of events 6
|
2.4%
3/124 • Number of events 3
|
|
Psychiatric disorders
METHADONE WITHDRAWAL
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Renal and urinary disorders
HEMATURIA
|
1.2%
3/244 • Number of events 3
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Renal and urinary disorders
NOCTURIA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Renal and urinary disorders
RENAL CALCULI
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
1.2%
3/255 • Number of events 3
|
0.81%
1/124 • Number of events 1
|
|
Renal and urinary disorders
URINARY INCONTINENCE/FREQUENCY/URGENCY
|
0.82%
2/244 • Number of events 2
|
0.76%
1/132 • Number of events 1
|
1.2%
3/255 • Number of events 3
|
0.81%
1/124 • Number of events 1
|
|
Reproductive system and breast disorders
ABNORMAL MENSES
|
0.00%
0/244
|
0.00%
0/132
|
0.78%
2/255 • Number of events 2
|
0.00%
0/124
|
|
Reproductive system and breast disorders
ATYPICAL PAP TEST
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
2.4%
3/124 • Number of events 3
|
|
Reproductive system and breast disorders
PROLAPSED UTERUS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Reproductive system and breast disorders
PROSTATE INFECTION/ENLARGEMENT
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE/BLEEDING
|
0.00%
0/244
|
1.5%
2/132 • Number of events 2
|
1.6%
4/255 • Number of events 4
|
2.4%
3/124 • Number of events 3
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA/COPD
|
1.6%
4/244 • Number of events 4
|
0.00%
0/132
|
1.2%
3/255 • Number of events 3
|
2.4%
3/124 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
CHEST PAIN
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
NOSE BLEED
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
1.6%
4/244 • Number of events 4
|
0.00%
0/132
|
2.0%
5/255 • Number of events 5
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEAL STENOSIS
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
BRITTLE FINGERNAILS
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
CHILLS/SWEATS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
DELAYED WOUND HEALING
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
DERMATALOGIC ERUPTION
|
14.8%
36/244 • Number of events 36
|
12.1%
16/132 • Number of events 16
|
14.5%
37/255 • Number of events 37
|
11.3%
14/124 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
INJURY
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
MELASMA
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
NASAL IRRITATION/EROSION
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
ORAL ULCERS
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.78%
2/255 • Number of events 2
|
4.0%
5/124 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
OTHER
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
OTHER INFECTION
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PEELING SKIN
|
0.00%
0/244
|
0.76%
1/132 • Number of events 1
|
0.00%
0/255
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
PETECHIA
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
PLANTAR FASCITIS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
POOR WOUND HEALING
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SUPRACLAVICULAR FAT PADS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Surgical and medical procedures
CATARACT
|
3.7%
9/244 • Number of events 9
|
0.00%
0/132
|
0.00%
0/255
|
0.81%
1/124 • Number of events 1
|
|
Surgical and medical procedures
DENTAL PAIN/INFECTION/ABSCESS
|
0.82%
2/244 • Number of events 2
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Surgical and medical procedures
DERMATALOGIC ERUPTION
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Surgical and medical procedures
FRACTURE
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Surgical and medical procedures
INJURY
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Surgical and medical procedures
JOINT SURGERY/PROCEDURE
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
1.6%
4/255 • Number of events 4
|
0.81%
1/124 • Number of events 1
|
|
Surgical and medical procedures
OTHER SURGERY/PROCEDURE
|
0.41%
1/244 • Number of events 1
|
1.5%
2/132 • Number of events 2
|
3.5%
9/255 • Number of events 9
|
6.5%
8/124 • Number of events 8
|
|
Vascular disorders
CLAUDICATION
|
0.00%
0/244
|
0.00%
0/132
|
0.00%
0/255
|
1.6%
2/124 • Number of events 2
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
|
Vascular disorders
NOSE BLEED
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Vascular disorders
PERIPHERAL VASCULAR DISEASE
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.00%
0/244
|
0.00%
0/132
|
0.39%
1/255 • Number of events 1
|
0.00%
0/124
|
|
Vascular disorders
VARICOSE VEIN
|
0.41%
1/244 • Number of events 1
|
0.00%
0/132
|
0.00%
0/255
|
0.00%
0/124
|
Additional Information
Dr. Jeffrey R. Curtis,
University of Alabama at Birmingham
Phone: 205-934-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60