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Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00544557
Recruitment Status : Completed
First Posted : October 16, 2007
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Ankylosing Spondylitis
Intervention Drug: Etanercept
Enrollment 1715
Recruitment Details  
Pre-assignment Details A total of 1715 participants were enrolled for documentation. Of these 1715 participants enrolled, only 1685 participants were included in analysis.
Arm/Group Title Etanercept
Hide Arm/Group Description Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Period Title: Overall Study
Started 1685
Completed 1251
Not Completed 434
Reason Not Completed
Adverse Event             140
Lack of Efficacy             196
Other             98
Arm/Group Title Etanercept
Hide Arm/Group Description Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Baseline Participants 1685
Hide Baseline Analysis Population Description
Safety population included all treated participants with available post-baseline safety data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1685 participants
43.9  (12.9)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1685 participants
Male 1067
Female 615
Missing 3
1.Primary Outcome
Title Percentage of Participants Achieving Partial Remission at Week 26
Hide Description Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants greater than or equal to (>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1305
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.0
(16.9 to 21.2)
2.Primary Outcome
Title Percentage of Participants Achieving Partial Remission at Week 52
Hide Description Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here ‘N’ signifies participants who were evaluable for this outcome measure.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.0
(20.6 to 25.6)
3.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non­-SAEs.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants with available post-baseline safety data.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1685
Measure Type: Number
Unit of Measure: percentage of participants
SAEs 7.6
AEs 38.2
4.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity
Hide Description [Not Specified]
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants with available post­-baseline safety data.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1685
Measure Type: Number
Unit of Measure: percentage of participants
SAEs NA [1] 
AEs NA [1] 
[1]
Data was not analyzed due to low number of participants.
5.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
Hide Description BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0–10 BASDAI score (0 being no problem and 10 being the worst problem).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1635) 5.327  (2.029)
Change at Week 52 (n=1128) -2.199  (2.163)
6.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
Hide Description BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0–10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0–10).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1626) 4.9  (2.4)
Change at Week 52 (n=1129) -1.7  (2.2)
7.Secondary Outcome
Title Change From Baseline in Occiput-to-Wall Distance at Week 52
Hide Description Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: centimeter (cm)
Baseline (n=1347) 6.7  (7.8)
Change at Week 52 (n=788) -0.7  (4.4)
8.Secondary Outcome
Title Change From Baseline in Lateral Lumbar Flexion at Week 52
Hide Description Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (n=1123) 11.8  (11.8)
Change at Week 52 (n=656) 1.0  (8.9)
9.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52
Hide Description Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1630) 6.5  (2.2)
Change at Week 52 (n=1117) -3.0  (2.8)
10.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52
Hide Description Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1602) 6.2  (2.3)
Change at Week 52 (n=1094) -3.1  (2.8)
11.Secondary Outcome
Title Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52
Hide Description Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1655) 6.4  (1.6)
Change at Week 52 (n=1171) -4.2  (2.2)
12.Secondary Outcome
Title Change From Baseline in Duration of Morning Stiffness at Week 52
Hide Description Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline (n=1641) 58.6  (59.2)
Change at Week 52 (n=1165) -37.0  (54.0)
13.Secondary Outcome
Title Percentage of Participants With Significant Reduction of Morning Stiffness
Hide Description Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).
Time Frame Week 2, 6, 12, 26, 38, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (n=1405) 51.6
Week 6 (n=1452) 62.1
Week 12 (n=1480) 67.2
Week 26 (n=1395) 68.0
Week 38 (n=1235) 69.8
Week 52 (n=1186) 70.6
14.Secondary Outcome
Title Percentage of Participants With Presence of Peripheral Arthritis
Hide Description Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.
Time Frame Baseline, Week 2, 6, 12, 26, 38, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=1663) 36.8
Week 2 (n=1405) 26.0
Week 6 (n=1452) 22.0
Week 12 (n=1480) 18.2
Week 26 (n=1395) 16.7
Week 38 (n=1235) 14.6
Week 52 (n=1186) 15.5
15.Secondary Outcome
Title Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52
Hide Description Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: joints
Baseline (n=1652) 2.2  (5.5)
Change at Week 52 (n=1174) -1.3  (5.2)
16.Secondary Outcome
Title Percentage of Participants With Presence of Enthesitis
Hide Description Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.
Time Frame Baseline, Week 2, 6, 12, 26, 38, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=1663) 20.6
Week 2 (n=1405) 14.7
Week 6 (n=1452) 11.5
Week 12 (n=1480) 9.5
Week 26 (n=1395) 8.5
Week 38 (n=1235) 7.4
Week 52 (n=1186) 7.9
17.Secondary Outcome
Title Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52
Hide Description Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: body parts
Baseline (n=1658) 0.6  (1.6)
Change at Week 52 (n=1174) -0.4  (1.4)
18.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 52
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n=1497) 2.6  (4.7)
Change at Week 52 (n=873) -1.6  (4.4)
19.Secondary Outcome
Title Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52
Hide Description ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: mm/hr
Baseline (n=1422) 26.9  (21.7)
Change at Week 52 (n=812) -14.2  (21.1)
20.Secondary Outcome
Title Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response
Hide Description ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least >= 20 percent improvement from baseline and an absolute change >=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.
Time Frame Week 12, 26, 38, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 (n=1480)
60.6
(58.0 to 63.3)
Week 26 (n=1395)
61.6
(58.9 to 64.3)
Week 38 (n=1235)
63.1
(60.3 to 66.0)
Week 52 (n=1186)
63.7
(60.7 to 66.5)
21.Secondary Outcome
Title Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (>=) 40 percent improvement from baseline and an absolute change >=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0–10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.
Time Frame Week 12, 26, 38, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 (n=1480)
44.1
(41.4 to 46.8)
Week 26 (n=1395)
46.7
(43.9 to 49.5)
Week 38 (n=1235)
48.6
(45.6 to 51.5)
Week 52 (n=1186)
51.0
(47.9 to 54.0)
22.Secondary Outcome
Title Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)
Hide Description EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self­care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.
Time Frame Baseline, Week 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1623) 0.58  (0.30)
Week 26 (n=1343) 0.80  (0.22)
Week 52 (n=1143) 0.82  (0.20)
23.Secondary Outcome
Title Euro Quality of Life (EQ­-5D)- Visual Analog Scale (VAS)
Hide Description EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.
Time Frame Baseline, Week 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1623) 54.3  (20.7)
Week 26 (n=1343) 71.9  (19.2)
Week 52 (n=1143) 74.2  (18.9)
24.Secondary Outcome
Title Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)
Hide Description WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Time Frame Baseline, Week 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: percentage of impairment
Baseline: Work Time Missed (n=776) 21.9  (36.3)
Baseline: Impairment While Working (n=890) 48.3  (26.9)
Baseline: Overall work impairment (n=716) 52.9  (29.8)
Baseline: Activity impairment (n = 1624) 58.1  (24.6)
Week 26: Work Time Missed (n = 666) 6.6  (20.6)
Week 26: Impairment While Working (n = 799) 27.3  (23.1)
Week 26: Overall work impairment (n = 657) 29.8  (25.9)
Week 26: Activity impairment (n = 1331) 34.6  (24.6)
Week 52: Work Time Missed (n = 588) 6.3  (19.2)
Week 52: Impairment While Working (n = 706) 24.6  (21.9)
Week 52: Overall work impairment (n = 578) 26.3  (24.2)
Week 52: Activity impairment (n = 1137) 32.3  (24.9)
25.Secondary Outcome
Title Healthcare Resource Utilization
Hide Description Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants’ healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.
Time Frame Baseline, Week 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here ‘N’ signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: events
Baseline: General Practitioner Visit (n=1654) 4.7  (8.3)
Baseline: Rheumatologist Visit (n=1657) 3.7  (3.3)
Baseline: Other Specialist Visit (n=1659) 1.6  (3.1)
Baseline: In-patient Hospitalization (n = 1658) 0.3  (0.9)
Baseline: In-patient Rehabilitation (n = 1657) 0.2  (1.6)
Baseline: Follow-up Treatment (n = 1662) 0.0  (0.1)
Baseline: Out-patient Rehabilitation (n = 1661) 0.0  (0.8)
Baseline: Physiotherapy (n = 1659) 9.1  (25.0)
Baseline: Out-patient Hospitalization (n = 1663) 0.0  (0.1)
Baseline: Ergotherapy (n = 1663) 0.0  (0.1)
Baseline: Other Health Care Resources (n = 1662) 0.7  (7.4)
Baseline: Sum Over All Care Resources (n = 1663) 20.3  (29.7)
Week 26: General Practitioner Visit (n = 1389) 2.2  (3.1)
Week 26: Rheumatologist Visit (n = 1392) 3.0  (2.6)
Week 26: Other Specialist Visit (n = 1393) 0.6  (1.5)
Week 26: In-patient Hospitalization (n = 1395) 0.1  (0.6)
Week 26: In-patient Rehabilitation (n = 1392) 0.2  (1.9)
Week 26: Follow-up Treatment (n = 1395) 0.0  (0.2)
Week 26: Out-patient Rehabilitation (n = 1395) 0.0  (0.8)
Week 26: Physiotherapy (n = 1395) 5.0  (14.1)
Week 26: Out-patient Hospitalization (n = 1394) 0.0  (0.0)
Week 26: Ergotherapy (n = 1395) 0.0  (0.5)
Week 26: Other Health Care Resources (n = 1390) 0.5  (4.5)
Week 26: Sum Over All Care Resources (n = 1395) 11.5  (16.9)
Week 52: General Practitioner Visit (n = 1184) 1.8  (3.8)
Week 52: Rheumatologist Visit (n = 1184) 2.0  (1.9)
Week 52: Other Specialist Visit (n = 1183) 0.6  (2.6)
Week 52: In-patient Hospitalization (n = 1186) 0.0  (0.2)
Week 52: In-patient Rehabilitation (n = 1186) 0.1  (0.9)
Week 52: Follow-up Treatment (n = 1186) 0.0  (0.0)
Week 52: Out-patient Rehabilitation (n = 1186) 0.0  (0.7)
Week 52: Physiotherapy (n = 1186) 4.3  (13.3)
Week 52: Out-patient Hospitalization (n = 1186) 0.0  (0.0)
Week 52: Ergotherapy (n = 1186) 0.0  (0.9)
Week 52: Other Health Care Resources (n = 1185) 0.7  (5.1)
Week 52: Sum Over All Care Resources (n = 1186) 9.6  (15.8)
26.Secondary Outcome
Title Duration of Healthcare Resources Utilization
Hide Description Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants’ healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants’ healthcare resources utilization were documented for last 6 months after previous documentation.
Time Frame Baseline, Week 26, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness population: all treated participants >=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1663
Mean (Standard Deviation)
Unit of Measure: days
Baseline: General Practitioner Visit (n=986) 3.7  (10.5)
Baseline: Rheumatologist Visit (n=928) 3.1  (5.7)
Baseline: Other Specialist Visit (n=1242) 0.9  (2.5)
Baseline: In-patient Hospitalization (n = 1633) 2.0  (5.7)
Baseline: In-patient Rehabilitation (n = 1648) 1.5  (6.0)
Baseline: Follow-up Treatment (n = 1661) 0.1  (1.8)
Baseline: Out-patient Rehabilitation (n = 1654) 0.2  (3.6)
Baseline: Physiotherapy (n = 1551) 6.2  (20.2)
Baseline: Out-patient Hospitalization (n = 1661) 0.0  (0.0)
Baseline: Ergotherapy (n = 1663) 0.0  (0.1)
Baseline: Other Health Care Resources (n = 1641) 0.4  (6.0)
Baseline: Sum Over All Care Resources (n = 1663) 14.5  (28.0)
Week 26: General Practitioner Visit (n = 917) 1.2  (2.1)
Week 26: Rheumatologist Visit (n = 834) 2.2  (2.7)
Week 26: Other Specialist Visit (n = 1190) 0.4  (1.9)
Week 26: In-patient Hospitalization (n = 1390) 0.3  (1.9)
Week 26: In-patient Rehabilitation (n = 1391) 1.0  (5.1)
Week 26: Follow-up Treatment (n = 1395) 0.0  (0.6)
Week 26: Out-patient Rehabilitation (n = 1394) 0.1  (1.2)
Week 26: Physiotherapy (n = 1350) 3.0  (9.9)
Week 26: Out-patient Hospitalization (n = 1395) 0.0  (0.0)
Week 26: Ergotherapy (n = 1393) 0.0  (0.4)
Week 26: Other Health Care Resources (n = 1376) 0.3  (4.0)
Week 26: Sum Over All Care Resources (n = 1395) 7.0  (14.5)
Week 52: General Practitioner Visit (n = 762) 1.0  (1.7)
Week 52: Rheumatologist Visit (n = 716) 1.5  (2.1)
Week 52: Other Specialist Visit (n = 1009) 0.3  (2.3)
Week 52: In-patient Hospitalization (n = 1177) 0.3  (2.0)
Week 52: In-patient Rehabilitation (n = 1185) 0.4  (3.0)
Week 52: Follow-up Treatment (n = 1186) 0.0  (0.0)
Week 52: Out-patient Rehabilitation (n = 1186) 0.2  (3.7)
Week 52: Physiotherapy (n = 1151) 2.6  (9.6)
Week 52: Out-patient Hospitalization (n = 1186) 0.0  (0.0)
Week 52: Ergotherapy (n = 1186) 0.0  (0.9)
Week 52: Other Health Care Resources (n = 1162) 0.2  (2.5)
Week 52: Sum Over All Care Resources (n = 1186) 5.4  (13.9)
27.Secondary Outcome
Title Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis
Hide Description Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants with available post-baseline safety data.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1685
Measure Type: Number
Unit of Measure: percentage of participants
Concomitant Medication 38.4
Prior Therapy 98.6
28.Secondary Outcome
Title Percentage of Participants With Discontinuation of Treatment Due to Adverse Events
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants with available post­-baseline safety data.
Arm/Group Title Etanercept
Hide Arm/Group Description:
Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
Overall Number of Participants Analyzed 1685
Measure Type: Number
Unit of Measure: percentage of participants
11.8
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Etanercept
Hide Arm/Group Description Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%)
Total   128/1685 (7.60%) 
Blood and lymphatic system disorders   
Bone marrow disorder * 1  1/1685 (0.06%) 
Cardiac disorders   
Coronary artery disease * 1  4/1685 (0.24%) 
Myocardial infarction * 1  4/1685 (0.24%) 
Angina pectoris * 1  2/1685 (0.12%) 
Atrial fibrillation * 1  2/1685 (0.12%) 
Acute myocardial infarction * 1  1/1685 (0.06%) 
Cardiac failure * 1  1/1685 (0.06%) 
Ischaemic cardiomyopathy * 1  1/1685 (0.06%) 
Mitral valve incompetence * 1  1/1685 (0.06%) 
Myocardial ischaemia * 1  1/1685 (0.06%) 
Pericardial effusion * 1  1/1685 (0.06%) 
Congenital, familial and genetic disorders   
Skull malformation * 1  1/1685 (0.06%) 
Endocrine disorders   
Goitre * 1  3/1685 (0.18%) 
Eye disorders   
Iritis * 1  2/1685 (0.12%) 
Cataract * 1  1/1685 (0.06%) 
Diplopia * 1  1/1685 (0.06%) 
Maculopathy * 1  1/1685 (0.06%) 
Gastrointestinal disorders   
Crohn's disease * 1  4/1685 (0.24%) 
Inguinal hernia * 1  2/1685 (0.12%) 
Nausea * 1  2/1685 (0.12%) 
Abdominal pain * 1  1/1685 (0.06%) 
Anal fistula * 1  1/1685 (0.06%) 
Diarrhoea * 1  1/1685 (0.06%) 
Pancreatitis acute * 1  1/1685 (0.06%) 
Pancreatitis chronic * 1  1/1685 (0.06%) 
Papilla of Vater stenosis * 1  1/1685 (0.06%) 
Subileus * 1  1/1685 (0.06%) 
Umbilical hernia * 1  1/1685 (0.06%) 
General disorders   
Condition aggravated * 1  5/1685 (0.30%) 
Drug ineffective * 1  2/1685 (0.12%) 
Oedema peripheral * 1  2/1685 (0.12%) 
Pain * 1  2/1685 (0.12%) 
Impaired healing * 1  1/1685 (0.06%) 
Injection site hypersensitivity * 1  1/1685 (0.06%) 
Hepatobiliary disorders   
Cholangitis * 1  2/1685 (0.12%) 
Cholelithiasis * 1  2/1685 (0.12%) 
Bile duct stone * 1  1/1685 (0.06%) 
Biliary colic * 1  1/1685 (0.06%) 
Cholecystitis acute * 1  1/1685 (0.06%) 
Liver disorder * 1  1/1685 (0.06%) 
Immune system disorders   
Sarcoidosis * 1  1/1685 (0.06%) 
Infections and infestations   
Pneumonia * 1  3/1685 (0.18%) 
Abdominal abscess * 1  1/1685 (0.06%) 
Anal abscess * 1  1/1685 (0.06%) 
Appendicitis * 1  1/1685 (0.06%) 
Arthritis bacterial * 1  1/1685 (0.06%) 
Bronchitis * 1  1/1685 (0.06%) 
Campylobacter gastroenteritis * 1  1/1685 (0.06%) 
Clostridium difficile colitis * 1  1/1685 (0.06%) 
Erysipelas * 1  1/1685 (0.06%) 
Meningitis aseptic * 1  1/1685 (0.06%) 
Meningitis viral * 1  1/1685 (0.06%) 
Pilonidal cyst * 1  1/1685 (0.06%) 
Pyelonephritis * 1  1/1685 (0.06%) 
Staphylococcal infection * 1  1/1685 (0.06%) 
Tonsillitis * 1  1/1685 (0.06%) 
Injury, poisoning and procedural complications   
Drug exposure during pregnancy * 1  2/1685 (0.12%) 
Joint dislocation * 1  2/1685 (0.12%) 
Tendon rupture * 1  2/1685 (0.12%) 
Ankle fracture * 1  1/1685 (0.06%) 
Cervical vertebral fracture * 1  1/1685 (0.06%) 
Fall * 1  1/1685 (0.06%) 
Fibula fracture * 1  1/1685 (0.06%) 
Injury * 1  1/1685 (0.06%) 
Ligament rupture * 1  1/1685 (0.06%) 
Lymphatic duct rupture * 1  1/1685 (0.06%) 
Meniscus lesion * 1  1/1685 (0.06%) 
Radius fracture * 1  1/1685 (0.06%) 
Road traffic accident * 1  1/1685 (0.06%) 
Seroma * 1  1/1685 (0.06%) 
Spinal fracture * 1  1/1685 (0.06%) 
Sports injury * 1  1/1685 (0.06%) 
Thoracic vertebral fracture * 1  1/1685 (0.06%) 
Tibia fracture * 1  1/1685 (0.06%) 
Investigations   
Arthroscopy * 1  1/1685 (0.06%) 
Transaminases increased * 1  1/1685 (0.06%) 
Metabolism and nutrition disorders   
Diabetes mellitus inadequate control * 1  1/1685 (0.06%) 
Type 2 diabetes mellitus * 1  1/1685 (0.06%) 
Musculoskeletal and connective tissue disorders   
Ankylosing spondylitis * 1  7/1685 (0.42%) 
Osteoarthritis * 1  4/1685 (0.24%) 
Fibromyalgia * 1  3/1685 (0.18%) 
Back pain * 1  2/1685 (0.12%) 
Intervertebral disc protrusion * 1  2/1685 (0.12%) 
Rotator cuff syndrome * 1  2/1685 (0.12%) 
Spondylitis * 1  2/1685 (0.12%) 
Arthralgia * 1  1/1685 (0.06%) 
Arthropathy * 1  1/1685 (0.06%) 
Dupuytren's contracture * 1  1/1685 (0.06%) 
Foot deformity * 1  1/1685 (0.06%) 
Joint ankylosis * 1  1/1685 (0.06%) 
Joint instability * 1  1/1685 (0.06%) 
Osteochondrosis * 1  1/1685 (0.06%) 
Rheumatoid arthritis * 1  1/1685 (0.06%) 
Bursitis * 1  1/1685 (0.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant melanoma * 1  3/1685 (0.18%) 
Malignant melanoma in situ * 1  2/1685 (0.12%) 
Uterine leiomyoma * 1  2/1685 (0.12%) 
Adenoma benign * 1  1/1685 (0.06%) 
Brain neoplasm * 1  1/1685 (0.06%) 
Endometrial cancer * 1  1/1685 (0.06%) 
Glioblastoma multiforme * 1  1/1685 (0.06%) 
Haemangioma * 1  1/1685 (0.06%) 
Intracranial haemangioma * 1  1/1685 (0.06%) 
Metastasis * 1  1/1685 (0.06%) 
Myelodysplastic syndrome * 1  1/1685 (0.06%) 
Oropharyngeal neoplasm benign * 1  1/1685 (0.06%) 
Renal cell carcinoma * 1  1/1685 (0.06%) 
Squamous cell carcinoma * 1  1/1685 (0.06%) 
Thyroid neoplasm * 1  1/1685 (0.06%) 
Squamous cell carcinoma of skin * 1  1/1685 (0.06%) 
Nervous system disorders   
Migraine with aura * 1  2/1685 (0.12%) 
Aphasia * 1  1/1685 (0.06%) 
Carotid artery occlusion * 1  1/1685 (0.06%) 
Cerebrovascular accident * 1  1/1685 (0.06%) 
Convulsion * 1  1/1685 (0.06%) 
Demyelination * 1  1/1685 (0.06%) 
Dysaesthesia * 1  1/1685 (0.06%) 
Dysgeusia * 1  1/1685 (0.06%) 
Hemianopia homonymous * 1  1/1685 (0.06%) 
Leukoencephalopathy * 1  1/1685 (0.06%) 
Monoplegia * 1  1/1685 (0.06%) 
Movement disorder * 1  1/1685 (0.06%) 
Paraesthesia * 1  1/1685 (0.06%) 
Paraplegia * 1  1/1685 (0.06%) 
Thalamic infarction * 1  1/1685 (0.06%) 
Transient ischaemic attack * 1  1/1685 (0.06%) 
VIIth nerve paralysis * 1  1/1685 (0.06%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/1685 (0.06%) 
Premature baby * 1  1/1685 (0.06%) 
Psychiatric disorders   
Psychogenic pain disorder * 1  2/1685 (0.12%) 
Acute stress disorder * 1  1/1685 (0.06%) 
Depression * 1  1/1685 (0.06%) 
Major depression * 1  1/1685 (0.06%) 
Psychotic disorder * 1  1/1685 (0.06%) 
Sleep disorder * 1  1/1685 (0.06%) 
Renal and urinary disorders   
Calculus ureteric * 1  2/1685 (0.12%) 
Nephrolithiasis * 1  2/1685 (0.12%) 
Renal colic * 1  1/1685 (0.06%) 
Urinary tract obstruction * 1  1/1685 (0.06%) 
Reproductive system and breast disorders   
Cervical polyp * 1  1/1685 (0.06%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea exertional * 1  1/1685 (0.06%) 
Sleep apnoea syndrome * 1  1/1685 (0.06%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  2/1685 (0.12%) 
Surgical and medical procedures   
Hip surgery * 1  1/1685 (0.06%) 
Implantable defibrillator insertion * 1  1/1685 (0.06%) 
Inguinal hernia repair * 1  1/1685 (0.06%) 
Myringoplasty * 1  1/1685 (0.06%) 
Removal of foreign body * 1  1/1685 (0.06%) 
Spinal fusion surgery * 1  1/1685 (0.06%) 
Tonsillectomy * 1  1/1685 (0.06%) 
Vascular disorders   
Hypertension * 1  2/1685 (0.12%) 
Haematoma * 1  1/1685 (0.06%) 
Peripheral arterial occlusive disease * 1  1/1685 (0.06%) 
Thrombosis * 1  1/1685 (0.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept
Affected / at Risk (%)
Total   588/1685 (34.90%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/1685 (0.06%) 
Anaemia macrocytic * 1  1/1685 (0.06%) 
Iron deficiency anaemia * 1  1/1685 (0.06%) 
Lymphadenopathy * 1  1/1685 (0.06%) 
Thrombocytopenia * 1  1/1685 (0.06%) 
Cardiac disorders   
Angina pectoris * 1  3/1685 (0.18%) 
Cardiovascular disorder * 1  2/1685 (0.12%) 
Coronary artery disease * 1  2/1685 (0.12%) 
Mitral valve incompetence * 1  2/1685 (0.12%) 
Palpitations * 1  2/1685 (0.12%) 
Bradycardia * 1  1/1685 (0.06%) 
Cardiac discomfort * 1  1/1685 (0.06%) 
Cardiac failure * 1  1/1685 (0.06%) 
Mitral valve prolapse * 1  1/1685 (0.06%) 
Ear and labyrinth disorders   
Ear pruritus * 1  1/1685 (0.06%) 
Inner ear inflammation * 1  1/1685 (0.06%) 
Sudden hearing loss * 1  1/1685 (0.06%) 
Tinnitus * 1  1/1685 (0.06%) 
Endocrine disorders   
Androgen deficiency * 1  1/1685 (0.06%) 
Cushing's syndrome * 1  1/1685 (0.06%) 
Eye disorders   
Iritis * 1  9/1685 (0.53%) 
Visual disturbance * 1  4/1685 (0.24%) 
Conjunctivitis * 1  3/1685 (0.18%) 
Ocular hyperaemia * 1  3/1685 (0.18%) 
Uveitis * 1  3/1685 (0.18%) 
Abnormal sensation in eye * 1  2/1685 (0.12%) 
Cataract * 1  2/1685 (0.12%) 
Dry eye * 1  2/1685 (0.12%) 
Iridocyclitis * 1  2/1685 (0.12%) 
Diplopia * 1  1/1685 (0.06%) 
Eye swelling * 1  1/1685 (0.06%) 
Eyelid oedema * 1  1/1685 (0.06%) 
Gastrointestinal disorders   
Diarrhoea * 1  19/1685 (1.13%) 
Nausea * 1  19/1685 (1.13%) 
Abdominal pain * 1  7/1685 (0.42%) 
Crohn's disease * 1  4/1685 (0.24%) 
Colitis ulcerative * 1  3/1685 (0.18%) 
Haemorrhoids * 1  3/1685 (0.18%) 
Periodontitis * 1  3/1685 (0.18%) 
Vomiting * 1  3/1685 (0.18%) 
Abdominal discomfort * 1  2/1685 (0.12%) 
Colitis * 1  2/1685 (0.12%) 
Gingival pain * 1  2/1685 (0.12%) 
Abdominal pain upper * 1  1/1685 (0.06%) 
Abdominal tenderness * 1  1/1685 (0.06%) 
Anal fissure * 1  1/1685 (0.06%) 
Anal fistula * 1  1/1685 (0.06%) 
Aphthous stomatitis * 1  1/1685 (0.06%) 
Breath odour * 1  1/1685 (0.06%) 
Chapped lips * 1  1/1685 (0.06%) 
Constipation * 1  1/1685 (0.06%) 
Dry mouth * 1  1/1685 (0.06%) 
Enteritis * 1  1/1685 (0.06%) 
Epiploic appendagitis * 1  1/1685 (0.06%) 
Frequent bowel movements * 1  1/1685 (0.06%) 
Gastric ulcer * 1  1/1685 (0.06%) 
Gastritis * 1  1/1685 (0.06%) 
Gastrooesophageal reflux disease * 1  1/1685 (0.06%) 
Gingival bleeding * 1  1/1685 (0.06%) 
Glossodynia * 1  1/1685 (0.06%) 
Haematochezia * 1  1/1685 (0.06%) 
Lip dry * 1  1/1685 (0.06%) 
Mouth ulceration * 1  1/1685 (0.06%) 
Pancreatitis * 1  1/1685 (0.06%) 
Proctalgia * 1  1/1685 (0.06%) 
Radicular cyst * 1  1/1685 (0.06%) 
Rectal haemorrhage * 1  1/1685 (0.06%) 
Stomach discomfort * 1  1/1685 (0.06%) 
Stomatitis * 1  1/1685 (0.06%) 
Umbilical hernia * 1  1/1685 (0.06%) 
General disorders   
Injection site erythema * 1  69/1685 (4.09%) 
Injection site pruritus * 1  21/1685 (1.25%) 
Injection site reaction * 1  25/1685 (1.48%) 
Condition aggravated * 1  20/1685 (1.19%) 
Fatigue * 1  14/1685 (0.83%) 
Injection site swelling * 1  13/1685 (0.77%) 
Injection site irritation * 1  10/1685 (0.59%) 
Oedema peripheral * 1  9/1685 (0.53%) 
Pyrexia * 1  9/1685 (0.53%) 
Injection site hypersensitivity * 1  5/1685 (0.30%) 
Chest pain * 1  4/1685 (0.24%) 
Local swelling * 1  4/1685 (0.24%) 
Drug ineffective * 1  3/1685 (0.18%) 
Drug intolerance * 1  3/1685 (0.18%) 
General physical health deterioration * 1  3/1685 (0.18%) 
Impaired healing * 1  3/1685 (0.18%) 
Injection site pain * 1  3/1685 (0.18%) 
Injection site urticaria * 1  3/1685 (0.18%) 
Pain * 1  3/1685 (0.18%) 
Injection site induration * 1  2/1685 (0.12%) 
Injection site macule * 1  2/1685 (0.12%) 
Injection site warmth * 1  2/1685 (0.12%) 
Tenderness * 1  2/1685 (0.12%) 
Application site erythema * 1  1/1685 (0.06%) 
Asthenia * 1  1/1685 (0.06%) 
Chest discomfort * 1  1/1685 (0.06%) 
Feeling hot * 1  1/1685 (0.06%) 
Granuloma * 1  1/1685 (0.06%) 
Injection site dermatitis * 1  1/1685 (0.06%) 
Injection site discolouration * 1  1/1685 (0.06%) 
Injection site necrosis * 1  1/1685 (0.06%) 
Injection site oedema * 1  1/1685 (0.06%) 
Injection site paraesthesia * 1  1/1685 (0.06%) 
Injection site rash * 1  1/1685 (0.06%) 
Local reaction * 1  1/1685 (0.06%) 
Localised oedema * 1  1/1685 (0.06%) 
Malaise * 1  1/1685 (0.06%) 
Sensation of foreign body * 1  1/1685 (0.06%) 
Hepatobiliary disorders   
Hepatic steatosis * 1  1/1685 (0.06%) 
Immune system disorders   
Hypersensitivity * 1  4/1685 (0.24%) 
Sarcoidosis * 1  1/1685 (0.06%) 
Seasonal allergy * 1  1/1685 (0.06%) 
Infections and infestations   
Nasopharyngitis * 1  59/1685 (3.50%) 
Bronchitis * 1  32/1685 (1.90%) 
Upper respiratory tract infection * 1  24/1685 (1.42%) 
Infection * 1  13/1685 (0.77%) 
Sinusitis * 1  9/1685 (0.53%) 
Urinary tract infection * 1  9/1685 (0.53%) 
Oral herpes * 1  8/1685 (0.47%) 
Respiratory tract infection * 1  8/1685 (0.47%) 
Pharyngitis * 1  7/1685 (0.42%) 
Febrile infection * 1  6/1685 (0.36%) 
Cystitis * 1  5/1685 (0.30%) 
Herpes simplex * 1  5/1685 (0.30%) 
Herpes zoster * 1  5/1685 (0.30%) 
Bronchopneumonia * 1  4/1685 (0.24%) 
Ear infection * 1  4/1685 (0.24%) 
Furuncle * 1  4/1685 (0.24%) 
Otitis media * 1  4/1685 (0.24%) 
Rhinitis * 1  4/1685 (0.24%) 
Tonsillitis * 1  4/1685 (0.24%) 
Acute tonsillitis * 1  3/1685 (0.18%) 
Laryngitis * 1  3/1685 (0.18%) 
Erysipelas * 1  2/1685 (0.12%) 
Folliculitis * 1  2/1685 (0.12%) 
Fungal skin infection * 1  2/1685 (0.12%) 
Gastroenteritis * 1  2/1685 (0.12%) 
Genital herpes * 1  1/1685 (0.06%) 
Infection susceptibility increased * 1  2/1685 (0.12%) 
Influenza * 1  2/1685 (0.12%) 
Rash pustular * 1  2/1685 (0.12%) 
Streptococcal infection * 1  2/1685 (0.12%) 
Tracheobronchitis * 1  2/1685 (0.12%) 
Acarodermatitis * 1  1/1685 (0.06%) 
Cellulitis of male external genital organ * 1  1/1685 (0.06%) 
Erythrasma * 1  1/1685 (0.06%) 
Gastroenteritis viral * 1  1/1685 (0.06%) 
Gastrointestinal candidiasis * 1  1/1685 (0.06%) 
Gastrointestinal infection * 1  1/1685 (0.06%) 
Genital candidiasis * 1  1/1685 (0.06%) 
Hepatitis B * 1  1/1685 (0.06%) 
Hordeolum * 1  1/1685 (0.06%) 
Injection site infection * 1  1/1685 (0.06%) 
Oophoritis * 1  1/1685 (0.06%) 
Otitis externa * 1  1/1685 (0.06%) 
Paronychia * 1  1/1685 (0.06%) 
Perirectal abscess * 1  1/1685 (0.06%) 
Peritonsillar abscess * 1  1/1685 (0.06%) 
Pilonidal cyst * 1  1/1685 (0.06%) 
Pneumonia * 1  1/1685 (0.06%) 
Pseudofolliculitis barbae * 1  1/1685 (0.06%) 
Respiratory tract infection viral * 1  1/1685 (0.06%) 
Soft tissue infection * 1  1/1685 (0.06%) 
Subcutaneous abscess * 1  1/1685 (0.06%) 
Tinea pedis * 1  1/1685 (0.06%) 
Tooth abscess * 1  1/1685 (0.06%) 
Vaginal candidiasis * 1  1/1685 (0.06%) 
Viral infection * 1  1/1685 (0.06%) 
Viral tonsillitis * 1  1/1685 (0.06%) 
Vulvovaginal mycotic infection * 1  1/1685 (0.06%) 
Wound infection staphylococcal * 1  1/1685 (0.06%) 
Campylobacter infection * 1  1/1685 (0.06%) 
Injury, poisoning and procedural complications   
Fall * 1  7/1685 (0.42%) 
Drug exposure during pregnancy * 1  3/1685 (0.18%) 
Meniscus lesion * 1  3/1685 (0.18%) 
Accident * 1  2/1685 (0.12%) 
Arthropod bite * 1  1/1685 (0.06%) 
Concussion * 1  1/1685 (0.06%) 
Excoriation * 1  1/1685 (0.06%) 
Foot fracture * 1  1/1685 (0.06%) 
Joint sprain * 1  1/1685 (0.06%) 
Overdose * 1  1/1685 (0.06%) 
Pelvic fracture * 1  1/1685 (0.06%) 
Radius fracture * 1  1/1685 (0.06%) 
Road traffic accident * 1  1/1685 (0.06%) 
Skeletal injury * 1  1/1685 (0.06%) 
Skin injury * 1  1/1685 (0.06%) 
Tendon rupture * 1  1/1685 (0.06%) 
Investigations   
Alanine aminotransferase increased * 1  9/1685 (0.53%) 
Gamma-glutamyltransferase increased * 1  7/1685 (0.42%) 
Liver function test abnormal * 1  6/1685 (0.36%) 
Hepatic enzyme increased * 1  4/1685 (0.24%) 
Blood alkaline phosphatase increased * 1  3/1685 (0.18%) 
Haemoglobin decreased * 1  3/1685 (0.18%) 
Transaminases increased * 1  3/1685 (0.18%) 
Weight increased * 1  3/1685 (0.18%) 
Arthroscopy * 1  2/1685 (0.12%) 
Aspartate aminotransferase increased * 1  2/1685 (0.12%) 
Blood creatinine increased * 1  2/1685 (0.12%) 
Investigation * 1  2/1685 (0.12%) 
Antinuclear antibody positive * 1  1/1685 (0.06%) 
Bacterial test positive * 1  1/1685 (0.06%) 
Biopsy prostate * 1  1/1685 (0.06%) 
Blood pressure increased * 1  1/1685 (0.06%) 
Blood urine present * 1  1/1685 (0.06%) 
C-reactive protein increased * 1  1/1685 (0.06%) 
DNA antibody positive * 1  1/1685 (0.06%) 
Diagnostic procedure * 1  1/1685 (0.06%) 
ECG signs of myocardial ischaemia * 1  1/1685 (0.06%) 
Heart rate increased * 1  1/1685 (0.06%) 
Laboratory test abnormal * 1  1/1685 (0.06%) 
Lipase increased * 1  1/1685 (0.06%) 
Lymphocyte count decreased * 1  1/1685 (0.06%) 
Red blood cell sedimentation rate increased * 1  1/1685 (0.06%) 
Weight decreased * 1  1/1685 (0.06%) 
White blood cell count decreased * 1  1/1685 (0.06%) 
Blood pressure diastolic increased * 1  1/1685 (0.06%) 
Metabolism and nutrition disorders   
Gout * 1  2/1685 (0.12%) 
Anorexia * 1  1/1685 (0.06%) 
Cow's milk intolerance * 1  1/1685 (0.06%) 
Obesity * 1  1/1685 (0.06%) 
Type 2 diabetes mellitus * 1  1/1685 (0.06%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  16/1685 (0.95%) 
Osteoarthritis * 1  7/1685 (0.42%) 
Joint swelling * 1  6/1685 (0.36%) 
Ankylosing spondylitis * 1  5/1685 (0.30%) 
Pain in extremity * 1  5/1685 (0.30%) 
Back pain * 1  4/1685 (0.24%) 
Myalgia * 1  4/1685 (0.24%) 
Enthesopathy * 1  3/1685 (0.18%) 
Joint range of motion decreased * 1  3/1685 (0.18%) 
Muscle spasms * 1  3/1685 (0.18%) 
Musculoskeletal pain * 1  3/1685 (0.18%) 
Myosclerosis * 1  3/1685 (0.18%) 
Neck pain * 1  3/1685 (0.18%) 
Rotator cuff syndrome * 1  3/1685 (0.18%) 
Tendonitis * 1  3/1685 (0.18%) 
Arthritis * 1  2/1685 (0.12%) 
Bone pain * 1  2/1685 (0.12%) 
Fibromyalgia * 1  2/1685 (0.12%) 
Intervertebral disc protrusion * 1  2/1685 (0.12%) 
Joint effusion * 1  2/1685 (0.12%) 
Muscle tightness * 1  2/1685 (0.12%) 
Muscular weakness * 1  2/1685 (0.12%) 
Rheumatoid arthritis * 1  2/1685 (0.12%) 
Tenosynovitis * 1  2/1685 (0.12%) 
Bursitis * 1  1/1685 (0.06%) 
Chondropathy * 1  1/1685 (0.06%) 
Dactylitis * 1  1/1685 (0.06%) 
Facet joint syndrome * 1  1/1685 (0.06%) 
Gouty tophus * 1  1/1685 (0.06%) 
Groin pain * 1  1/1685 (0.06%) 
Lumbar spinal stenosis * 1  1/1685 (0.06%) 
Muscle disorder * 1  1/1685 (0.06%) 
Musculoskeletal discomfort * 1  1/1685 (0.06%) 
Musculoskeletal stiffness * 1  1/1685 (0.06%) 
Osteitis * 1  1/1685 (0.06%) 
Pain in jaw * 1  1/1685 (0.06%) 
Periarthritis * 1  1/1685 (0.06%) 
Sacroiliitis * 1  1/1685 (0.06%) 
Spinal osteoarthritis * 1  1/1685 (0.06%) 
Synovial cyst * 1  1/1685 (0.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon adenoma * 1  1/1685 (0.06%) 
Melanocytic naevus * 1  1/1685 (0.06%) 
Skin papilloma * 1  1/1685 (0.06%) 
Superficial spreading melanoma stage unspecified * 1  1/1685 (0.06%) 
Nervous system disorders   
Headache * 1  18/1685 (1.07%) 
Dizziness * 1  11/1685 (0.65%) 
Paraesthesia * 1  5/1685 (0.30%) 
Carpal tunnel syndrome * 1  4/1685 (0.24%) 
Sciatica * 1  4/1685 (0.24%) 
Syncope * 1  4/1685 (0.24%) 
Hypoaesthesia * 1  3/1685 (0.18%) 
Cervical root pain * 1  2/1685 (0.12%) 
Cervicobrachial syndrome * 1  2/1685 (0.12%) 
Movement disorder * 1  2/1685 (0.12%) 
Sensory disturbance * 1  2/1685 (0.12%) 
Amnesia * 1  1/1685 (0.06%) 
Areflexia * 1  1/1685 (0.06%) 
Autonomic nervous system imbalance * 1  1/1685 (0.06%) 
Dysaesthesia * 1  1/1685 (0.06%) 
Dysgeusia * 1  1/1685 (0.06%) 
Hyperaesthesia * 1  1/1685 (0.06%) 
Intercostal neuralgia * 1  1/1685 (0.06%) 
Meralgia paraesthetica * 1  1/1685 (0.06%) 
Restless legs syndrome * 1  1/1685 (0.06%) 
Somnolence * 1  1/1685 (0.06%) 
Syncope vasovagal * 1  1/1685 (0.06%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  6/1685 (0.36%) 
Delivery * 1  1/1685 (0.06%) 
First trimester pregnancy * 1  1/1685 (0.06%) 
Psychiatric disorders   
Depression * 1  5/1685 (0.30%) 
Depressed mood * 1  2/1685 (0.12%) 
Insomnia * 1  2/1685 (0.12%) 
Agitation * 1  1/1685 (0.06%) 
Alcohol abuse * 1  1/1685 (0.06%) 
Libido decreased * 1  1/1685 (0.06%) 
Mood swings * 1  1/1685 (0.06%) 
Panic attack * 1  1/1685 (0.06%) 
Somatoform disorder * 1  1/1685 (0.06%) 
Tobacco abuse * 1  1/1685 (0.06%) 
Renal and urinary disorders   
Calculus urinary * 1  1/1685 (0.06%) 
Dysuria * 1  1/1685 (0.06%) 
Pollakiuria * 1  1/1685 (0.06%) 
Renal colic * 1  1/1685 (0.06%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  3/1685 (0.18%) 
Genital erythema * 1  1/1685 (0.06%) 
Menstruation irregular * 1  1/1685 (0.06%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  7/1685 (0.42%) 
Pharyngolaryngeal pain * 1  7/1685 (0.42%) 
Dyspnoea * 1  5/1685 (0.30%) 
Chronic obstructive pulmonary disease * 1  3/1685 (0.18%) 
Dyspnoea exertional * 1  2/1685 (0.12%) 
Respiratory distress * 1  2/1685 (0.12%) 
Rhonchi * 1  2/1685 (0.12%) 
Sneezing * 1  2/1685 (0.12%) 
Sputum discoloured * 1  2/1685 (0.12%) 
Wheezing * 1  2/1685 (0.12%) 
Dysphonia * 1  1/1685 (0.06%) 
Emphysema * 1  1/1685 (0.06%) 
Epistaxis * 1  1/1685 (0.06%) 
Lung disorder * 1  1/1685 (0.06%) 
Nasal dryness * 1  1/1685 (0.06%) 
Painful respiration * 1  1/1685 (0.06%) 
Productive cough * 1  1/1685 (0.06%) 
Rhinitis allergic * 1  1/1685 (0.06%) 
Throat tightness * 1  1/1685 (0.06%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  18/1685 (1.07%) 
Acne * 1  2/1685 (0.12%) 
Alopecia * 1  3/1685 (0.18%) 
Blister * 1  2/1685 (0.12%) 
Dermatitis * 1  3/1685 (0.18%) 
Dermatitis allergic * 1  9/1685 (0.53%) 
Dermatitis atopic * 1  1/1685 (0.06%) 
Drug eruption * 1  1/1685 (0.06%) 
Dry skin * 1  2/1685 (0.12%) 
Eczema * 1  8/1685 (0.47%) 
Erythema * 1  17/1685 (1.01%) 
Erythema nodosum * 1  1/1685 (0.06%) 
Exfoliative rash * 1  1/1685 (0.06%) 
Generalised erythema * 1  1/1685 (0.06%) 
Hyperhidrosis * 1  4/1685 (0.24%) 
Nail psoriasis * 1  1/1685 (0.06%) 
Night sweats * 1  2/1685 (0.12%) 
Periorbital oedema * 1  1/1685 (0.06%) 
Pruritus generalised * 1  2/1685 (0.12%) 
Psoriasis * 1  10/1685 (0.59%) 
Pustular psoriasis * 1  4/1685 (0.24%) 
Rash * 1  10/1685 (0.59%) 
Rash generalised * 1  2/1685 (0.12%) 
Rash pruritic * 1  3/1685 (0.18%) 
Skin reaction * 1  3/1685 (0.18%) 
Urticaria * 1  2/1685 (0.12%) 
Petechiae * 1  1/1685 (0.06%) 
Photosensitivity reaction * 1  1/1685 (0.06%) 
Rash macular * 1  1/1685 (0.06%) 
Rash papular * 1  1/1685 (0.06%) 
Rash vesicular * 1  1/1685 (0.06%) 
Skin burning sensation * 1  1/1685 (0.06%) 
Skin disorder * 1  1/1685 (0.06%) 
Skin exfoliation * 1  1/1685 (0.06%) 
Skin induration * 1  1/1685 (0.06%) 
Skin irritation * 1  1/1685 (0.06%) 
Skin nodule * 1  1/1685 (0.06%) 
Skin ulcer * 1  1/1685 (0.06%) 
Surgical and medical procedures   
Hospitalisation * 1  4/1685 (0.24%) 
Carpal tunnel decompression * 1  2/1685 (0.12%) 
Synoviorthesis * 1  2/1685 (0.12%) 
Abortion induced * 1  1/1685 (0.06%) 
Angioplasty * 1  1/1685 (0.06%) 
Ankle operation * 1  1/1685 (0.06%) 
Arterial stent insertion * 1  1/1685 (0.06%) 
Baker's cyst excision * 1  1/1685 (0.06%) 
Cataract operation * 1  1/1685 (0.06%) 
Catheterisation cardiac * 1  1/1685 (0.06%) 
Dental operation * 1  1/1685 (0.06%) 
Dental treatment * 1  1/1685 (0.06%) 
Hip arthroplasty * 1  1/1685 (0.06%) 
Infiltration anaesthesia * 1  1/1685 (0.06%) 
Knee arthroplasty * 1  1/1685 (0.06%) 
Ligament operation * 1  1/1685 (0.06%) 
Neurolysis * 1  1/1685 (0.06%) 
Osteotomy * 1  1/1685 (0.06%) 
Skin operation * 1  1/1685 (0.06%) 
Spinal deformity correction * 1  1/1685 (0.06%) 
Surgery * 1  1/1685 (0.06%) 
Tendon operation * 1  1/1685 (0.06%) 
Tendon sheath incision * 1  1/1685 (0.06%) 
Tonsillectomy * 1  1/1685 (0.06%) 
Tooth extraction * 1  1/1685 (0.06%) 
Vascular disorders   
Hypertension * 1  8/1685 (0.47%) 
Cardiovascular insufficiency * 1  2/1685 (0.12%) 
Thrombosis * 1  2/1685 (0.12%) 
Haematoma * 1  1/1685 (0.06%) 
Hot flush * 1  1/1685 (0.06%) 
Hypertensive crisis * 1  1/1685 (0.06%) 
Hypotension * 1  1/1685 (0.06%) 
Orthostatic hypotension * 1  1/1685 (0.06%) 
Peripheral arterial occlusive disease * 1  1/1685 (0.06%) 
Thrombophlebitis * 1  1/1685 (0.06%) 
Varicose vein * 1  1/1685 (0.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1­-800­-718-­1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00544557     History of Changes
Other Study ID Numbers: 0881X1-4463
B1801087 ( Other Identifier: Alias Study Number )
First Submitted: October 15, 2007
First Posted: October 16, 2007
Results First Submitted: April 23, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015