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Trial record 57 of 298 for:    "Ankylosing spondylitis"

Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

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ClinicalTrials.gov Identifier: NCT01079182
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : June 1, 2015
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Ankylosing Spondylitis
Enrollment 4681
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ankylosing Spondylitis
Hide Arm/Group Description Participants with ankylosing spondylitis
Period Title: Overall Study
Started 4681
Completed 1962
Not Completed 2719
Reason Not Completed
Lost to Follow-up             1634
Adverse Drug Reaction (ADR)             261
Lack of Efficacy             514
ADR and Lack of Effectiveness             39
Reasons not Evaluated             271
Arm/Group Title Ankylosing Spondylitis
Hide Arm/Group Description Participants with ankylosing spondylitis
Overall Number of Baseline Participants 4681
Hide Baseline Analysis Population Description
A total of 4681 participants enrolled in the study, but the complete set of parameters was not available for each participant (Age and gender, N=4680; duration of AS symptoms, N=4521; HLA-B27 positive, N=3807).
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4681 participants
43.1  (12.1)
[1]
Measure Description: N= 4680 as the complete set of parameters was not available for each participant.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4681 participants
Female 1620
Male 3060
[1]
Measure Description: N= 4680 as the complete set of parameters was not available for each participant.
Duration of Ankylosing Spondylitis (AS) Symptoms  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4681 participants
14.4  (10.8)
Human Leukocyte Antigen (HLA) B27 Positive Status  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 4681 participants
84.4
1.Primary Outcome
Title Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Hide Description The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3756
Mean (Standard Deviation)
Unit of Measure: BASDAI score
Baseline 5.5  (1.9)
Change from Baseline at Month 3 (N=3575) -2.0  (2.0)
Change from Baseline at Month 6 (N=3181) -2.1  (2.1)
Change from Baseline at Month 9 (N=2828) -2.2  (2.2)
Change from Baseline at Month 12 (N=2585) -2.3  (2.2)
Change from Baseline at Month 18 (N=2169) -2.3  (2.3)
Change from Baseline at Month 24 (N=1799) -2.3  (2.3)
2.Primary Outcome
Title Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
Hide Description The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3743
Mean (Standard Deviation)
Unit of Measure: BASFI score
Baseline 4.9  (2.4)
Change from Baseline at Month 3 (N=3565) -1.4  (1.9)
Change from Baseline at Month 6 (N=3180) -1.5  (2.0)
Change from Baseline at Month 9 (N=2821) -1.6  (2.1)
Change from Baseline at Month 12 (N=2572) -1.6  (2.1)
Change from Baseline at Month 18 (N=2160) -1.7  (2.2)
Change from Baseline at Month 24 (N=1793) -1.7  (2.2)
3.Primary Outcome
Title Number of Participants With Drug-Related Adverse Events (AEs)
Hide Description An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.
Time Frame From signing of informed consent up to 24 months
Hide Outcome Measure Data
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Safety analysis set: Participants who received at least one dose of adalimumab.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 4681
Measure Type: Number
Unit of Measure: Participants
1099
4.Secondary Outcome
Title Mean Number of Involved Peripheral Joints
Hide Description Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3715
Mean (Standard Deviation)
Unit of Measure: Joints
TJC at Baseline 3.1  (7.2)
TJC at Month 3 (N=3576) 1.8  (6.0)
TJC at Month 6 (N=3172) 1.6  (5.6)
TJC at Month 9 (N=2821) 1.6  (5.7)
TJC at Month 12 (N=2583) 1.5  (6.1)
TJC at Month 18 (N=2162) 1.5  (5.4)
TJC at Month 24 (N=1804) 1.2  (5.0)
SJC at Baseline 1.3  (4.5)
SJC at Month 3 (N=3576) 0.7  (3.4)
SJC at Month 6 (N=3172) 0.6  (3.0)
SJC at Month 9 (N=2821) 0.5  (2.9)
SJC at Month 12 (N=2583) 0.4  (2.3)
SJC at Month 18 (N=2162) 0.5  (3.1)
SJC at Month 24 (N=1804) 0.4  (2.3)
5.Secondary Outcome
Title Percentage of Participants With Extraspinal Manifestations
Hide Description Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3756
Measure Type: Number
Unit of Measure: Percentage of participants
Enthesitis at Baseline 13.6
Enthesitis at Month 3 (N=3616) 5.6
Enthesitis at Month 6 (N=3216) 3.7
Enthesitis at Month 9 (N=2858) 4.1
Enthesitis at Month 12 (N=2603) 4.5
Enthesitis at Month 18 (N=2183) 3.5
Enthesitis at Month 24 (N=1823) 3.4
Dactylitis at Baseline 5.4
Dactylitis at Month 3 (N=3616) 2.4
Dactylitis at Month 6 (N=3216) 1.6
Dactylitis at Month 9 (N=2858) 1.3
Dactylitis at Month 12 (N=2603) 1.6
Dactylitis at Month 18 (N=2183) 1.3
Dactylitis at Month 24 (N=1823) 1.9
Uveitis at Baseline 3.3
Uveitis at Month 3 (N=3616) 1.1
Uveitis at Month 6 (N=3216) 0.9
Uveitis at Month 9 (N=2858) 0.7
Uveitis at Month 12 (N=2603) 0.5
Uveitis at Month 18 (N=2183) 0.5
Uveitis at Month 24 (N=1823) 0.7
Psoriasis at Baseline 5.4
Psoriasis at Month 3 (N=3616) 2.9
Psoriasis at Month 6 (N=3216) 2.7
Psoriasis at Month 9 (N=2858) 2.6
Psoriasis at Month 12 (N=2603) 2.5
Psoriasis at Month 18 (N=2183) 2.3
Psoriasis at Month 24 (N=1823) 2.8
IBD at Baseline 4.4
IBD at Month 3 (N=3616) 2.6
IBD at Month 6 (N=3216) 1.8
IBD at Month 9 (N=2858) 1.9
IBD at Month 12 (N=2603) 1.7
IBD at Month 18 (N=2183) 1.4
IBD at Month 24 (N=1823) 1.9
6.Secondary Outcome
Title Mean Erythrocyte Sedimentation Rate (ESR)
Hide Description Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3514
Mean (Standard Deviation)
Unit of Measure: mm/hour
Baseline 26.8  (21.6)
At Month 3 (N=3231) 12.9  (14.1)
At Month 6 (N=2888) 13.3  (15.1)
At Month 9 (N=2540) 13.6  (15.3)
At Month 12 (N=2288) 13.3  (14.1)
At Month 18 (N=1932) 13.3  (13.6)
At Month 24 (N=1627) 14.0  (13.7)
7.Secondary Outcome
Title Mean Plasma Concentrations of C-Reactive Protein (CRP)
Hide Description Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3638
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline 17.1  (21.8)
At Month 3 (N=3277) 6.2  (11.0)
At Month 6 (N=2934) 6.5  (13.4)
At Month 9 (N=2601) 6.3  (11.9)
At Month 12 (N=2344) 6.0  (11.9)
At Month 18 (N=2004) 5.5  (9.1)
At Month 24 (N=1687) 5.8  (9.5)
8.Secondary Outcome
Title Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score
Hide Description The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3734
Mean (Standard Deviation)
Unit of Measure: BAS-G score
Baseline 6.7  (2.0)
At Month 3 (N=3562) 4.8  (2.2)
At Month 6 (N=3178) 4.1  (2.4)
At Month 9 (N=2832) 3.8  (2.4)
At Month 12 (N=2574) 3.6  (2.4)
At Month 18 (N=2162) 3.5  (2.4)
At Month 24 (N=1796) 3.4  (2.4)
9.Secondary Outcome
Title Mean Global Assessment of Disease Activity Score
Hide Description Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3744
Mean (Standard Deviation)
Unit of Measure: Score on scale
Baseline 6.5  (1.7)
At Month 3 (N=3574) 3.1  (2.1)
At Month 6 (N=3174) 2.8  (2.1)
At Month 9 (N=2831) 2.6  (2.0)
At Month 12 (N=2574) 2.4  (1.9)
At Month 18 (N=2161) 2.3  (1.9)
At Month 24 (N=1805) 2.2  (1.9)
10.Secondary Outcome
Title Mean Participant Fatigue Score
Hide Description Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3756
Mean (Standard Deviation)
Unit of Measure: Score on scale
Baseline 5.9  (2.3)
At Month 3 (N=3585) 4.3  (2.5)
At Month 6 (N=3189) 4.2  (2.5)
At Month 9 (N=2837) 4.0  (2.5)
At Month 12 (N=2591) 3.9  (2.5)
At Month 18 (N=2174) 3.8  (2.4)
At Month 24 (N=1803) 3.8  (2.5)
11.Secondary Outcome
Title Mean Participant Pain Score
Hide Description Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3756
Mean (Standard Deviation)
Unit of Measure: Score on scale
Baseline 6.7  (2.3)
At Month 3 (N=3586) 4.0  (2.6)
At Month 6 (N=3191) 3.9  (2.6)
At Month 9 (N=2839) 3.8  (2.6)
At Month 12 (N=2589) 3.7  (2.5)
At Month 18 (N=2173) 3.5  (2.5)
At Month 24 (N=1804) 3.5  (2.5)
12.Secondary Outcome
Title Percentage of Participants With Morning Stiffness
Hide Description Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3756
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 95.4
At Month 3 (N=3582) 81.8
At Month 6 (N=3186) 79.9
At Month 9 (N=2835) 78.8
At Month 12 (N=2589) 77.6
At Month 18 (N=2173) 77.6
At Month 24 (N=1802) 77.8
13.Secondary Outcome
Title Mean Duration of Morning Stiffness
Hide Description Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3756
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline 56.7  (34.5)
At Month 3 (N=3582) 33.5  (30.7)
At Month 6 (N=3186) 31.3  (30.0)
At Month 9 (N=2835) 29.6  (28.7)
At Month 12 (N=2589) 28.6  (28.2)
At Month 18 (N=2173) 27.7  (27.4)
At Month 24 (N=1802) 27.4  (27.0)
14.Secondary Outcome
Title Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria
Hide Description This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.
Time Frame At 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3349
Measure Type: Number
Unit of Measure: Percentage of participants
ASAS 20 Improvement at Month 3 57.9
ASAS 20 Improvement at Month 6 (N=2989) 63.0
ASAS 20 Improvement at Month 9 (N=2661) 64.3
ASAS 20 Improvement at Month 12 (N=2419) 65.6
ASAS 20 Improvement at Month 18 (N=2030) 66.9
ASAS 20 Improvement at Month 24 (N=1688) 67.2
ASAS 40 Improvement at Month 3 36.4
ASAS 40 Improvement at Month 6 (N=2989) 40.1
ASAS 40 Improvement at Month 9 (N=2661) 42.5
ASAS 40 Improvement at Month 12 (N=2419) 43.7
ASAS 40 Improvement at Month 18 (N=2030) 45.9
ASAS 40 Improvement at Month 24 (N=1688) 46.8
15.Secondary Outcome
Title Percentage of Participants Achieving ASAS Partial Remission Criteria
Hide Description This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3731
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 1.1
Month 3 (N=3537) 17.7
Month 6 (N=3128) 21.5
Month 9 (N=2785) 23.3
Month 12 (N=2535) 23.9
Month 18 (N=2132) 24.9
Month 24 (N=1782) 26.8
16.Secondary Outcome
Title Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks
Hide Description The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3654
Measure Type: Number
Unit of Measure: Percentage of participants
0 Days at Baseline 23.0
0 Days at Month 3 (N=3496) 47.2
0 Days at Month 6 (N=3121) 52.6
0 Days at Month 9 (N=2793) 55.9
0 Days at Month 12 (N=2524) 57.1
0 Days at Month 18 (N=2130) 60.2
0 Days at Month 24 (N=1766) 60.9
Less Than 7 Days at Baseline 28.5
Less Than 7 Days at Month 3 (N=3496) 30.3
Less Than 7 Days at Month 6 (N=3121) 28.5
Less Than 7 Days at Month 9 (N=2793) 27.2
Less Than 7 Days at Month 12 (N=2524) 27.2
Less Than 7 Days at Month 18 (N=2130) 24.4
Less Than 7 Days at Month 24 (N=1766) 24.0
7 to 14 Days at Baseline 23.4
7 to 14 Days at Month 3 (N=3496) 11.6
7 to 14 Days at Month 6 (N=3121) 9.9
7 to 14 Days at Month 9 (N=2793) 9.6
7 to 14 Days at Month 12 (N=2524) 8.9
7 to 14 Days at Month 18 (N=2130) 8.8
7 to 14 Days at Month 24 (N=1766) 8.9
Greater Than 14 Days at Baseline 25.1
Greater Than 14 Days at Month 3 (N=3496) 11.0
Greater Than 14 Days at Month 6 (N=3121) 9.0
Greater Than 14 Days at Month 9 (N=2793) 7.3
Greater Than 14 Days at Month 12 (N=2524) 6.8
Greater Than 14 Days at Month 18 (N=2130) 6.6
Greater Than 14 Days at Month 24 (N=1766) 6.1
17.Secondary Outcome
Title Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months
Hide Description [Not Specified]
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 2217
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 45.7
At Month 3 (N=2082) 39.3
At Month 6 (N=1870) 32.2
At Month 9 (N=1673) 26.3
At Month 12 (N=1549) 21.3
At Month 18 (N=1331) 17.2
At Month 24 (N=1105) 14.2
18.Secondary Outcome
Title Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months
Hide Description [Not Specified]
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 2217
Mean (Standard Deviation)
Unit of Measure: Days
Baseline 48.0  (69.1)
At Month 3 (N=2082) 52.2  (74.3)
At Month 6 (N=1870) 56.0  (85.7)
At Month 9 (N=1673) 50.5  (81.7)
At Month 12 (N=1549) 48.0  (80.1)
At Month 18 (N=1331) 35.3  (61.4)
At Month 24 (N=1105) 35.4  (61.3)
19.Secondary Outcome
Title Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Hide Description [Not Specified]
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3692
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 20.6
At Month 3 (N=3521) 18.9
At Month 6 (N=3134) 16.9
At Month 9 (N=2798) 12.9
At Month 12 (N=2538) 8.4
At Month 18 (N=2133) 4.7
At Month 24 (N=1762) 3.8
20.Secondary Outcome
Title Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months
Hide Description [Not Specified]
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3692
Mean (Standard Deviation)
Unit of Measure: Days
Baseline 16.0  (14.7)
At Month 3 (N=3521) 15.1  (12.6)
At Month 6 (N=3134) 16.3  (21.5)
At Month 9 (N=2798) 17.2  (26.4)
At Month 12 (N=2538) 18.8  (33.9)
At Month 18 (N=2133) 17.7  (12.4)
At Month 24 (N=1762) 15.3  (11.9)
21.Secondary Outcome
Title Percentage of Participants on Adalimumab Monotherapy
Hide Description [Not Specified]
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3744
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline 78.8
At Month 3 (N=3591) 81.6
At Month 6 (N=3202) 82.8
At Month 9 (N=2848) 83.2
At Month 12 (N=2598) 83.6
At Month 18 (N=2179) 83.7
At Month 24 (N=1816) 84.6
22.Secondary Outcome
Title Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Hide Description [Not Specified]
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
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Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3744
Measure Type: Number
Unit of Measure: Percentage of participants
Methotrexate at Baseline 13.0
Methotrexate at Month 3 (N=3591) 11.9
Methotrexate at Month 6 (N=3202) 11.9
Methotrexate at Month 9 (N=2848) 11.6
Methotrexate at Month 12 (N=2598) 11.5
Methotrexate at Month 18 (N=2179) 11.6
Methotrexate at Month 24 (N=1816) 11.0
Sulfasalazine at Baseline 7.5
Sulfasalazine at Month 3 (N=3591) 5.2
Sulfasalazine at Month 6 (N=3202) 4.2
Sulfasalazine at Month 9 (N=2848) 3.9
Sulfasalazine at Month 12 (N=2598) 3.8
Sulfasalazine at Month 18 (N=2179) 3.7
Sulfasalazine at Month 24 (N=1816) 3.3
Other DMARDs at Baseline 2.3
Other DMARDs at Month 3 (N=3591) 1.9
Other DMARDs at Month 6 (N=3202) 1.8
Other DMARDs at Month 9 (N=2848) 2.0
Other DMARDs at Month 12 (N=2598) 1.8
Other DMARDs at Month 18 (N=2179) 1.6
Other DMARDs at Month 24 (N=1816) 1.5
23.Secondary Outcome
Title Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents
Hide Description Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
Hide Outcome Measure Data
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
Hide Arm/Group Description:
Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3744
Measure Type: Number
Unit of Measure: Percentage of participants
Analgesics at Baseline 17.5
Analgesics at Month 3 (N=3591) 12.4
Analgesics at Month 6 (N=3202) 11.8
Analgesics at Month 9 (N=2848) 11.1
Analgesics at Month 12 (N=2598) 11.2
Analgesics at Month 18 (N=2179) 10.1
Analgesics at Month 24 (N=1816) 10.3
NSAIDs at Baseline 52.3
NSAIDs at Month 3 (N=3591) 36.1
NSAIDs at Month 6 (N=3202) 33.5
NSAIDs at Month 9 (N=2848) 31.4
NSAIDs at Month 12 (N=2598) 30.2
NSAIDs at Month 18 (N=2179) 31.3
NSAIDs at Month 24 (N=1816) 30.2
COX-2 Inhibitors at Baseline 21.4
COX-2 Inhibitors at Month 3 (N=3591) 16.5
COX-2 Inhibitors at Month 6 (N=3202) 15.4
COX-2 Inhibitors at Month 9 (N=2848) 15.0
COX-2 Inhibitors at Month 12 (N=2598) 14.5
COX-2 Inhibitors at Month 18 (N=2179) 14.0
COX-2 Inhibitors at Month 24 (N=1816) 13.3
Systemic Glucocorticoids at Baseline 22.9
Systemic Glucocorticoids at Month 3 (N=3591) 15.2
Systemic Glucocorticoids at Month 6 (N=3202) 13.1
Systemic Glucocorticoids at Month 9 (N=2848) 11.8
Systemic Glucocorticoids at Month 12 (N=2598) 11.9
Systemic Glucocorticoids at Month 18 (N=2179) 11.3
Systemic Glucocorticoids at Month 24 (N=1816) 11.0
24.Secondary Outcome
Title Mean Equivalent Dose of Prednisolone
Hide Description The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.
Time Frame At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
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Full analysis set: Participants with adequate data available for evaluation of effectiveness.
Arm/Group Title Ankylosing Spondylitis
Hide Arm/Group Description:
Participants with ankylosing spondylitis
Overall Number of Participants Analyzed 3744
Mean (Standard Deviation)
Unit of Measure: mg/day
Baseline 10.5  (15.2)
At Month 3 (N=3591) 6.6  (5.0)
At Month 6 (N=3202) 6.8  (6.6)
At Month 9 (N=2848) 6.4  (6.1)
At Month 12 (N=2598) 7.2  (14.9)
At Month 18 (N=2179) 6.0  (7.0)
At Month 24 (N=1816) 5.6  (3.8)
Time Frame From signing of informed consent up to 24 months
Adverse Event Reporting Description Drug related AEs and all serious adverse events (SAEs) were collected during the study period.
 
Arm/Group Title Ankylosing Spondylitis
Hide Arm/Group Description Participants with ankylosing spondylitis
All-Cause Mortality
Ankylosing Spondylitis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ankylosing Spondylitis
Affected / at Risk (%)
Total   141/4681 (3.01%) 
Blood and lymphatic system disorders   
Lymphadenitis * 1  1/4681 (0.02%) 
Lymphadenopathy * 1  1/4681 (0.02%) 
Thrombocytopenia * 1  1/4681 (0.02%) 
Cardiac disorders   
Acute myocardial infarction * 1  3/4681 (0.06%) 
Cardiac failure * 1  3/4681 (0.06%) 
Atrial fibrillation * 1  2/4681 (0.04%) 
Myocardial infarction * 1  2/4681 (0.04%) 
Arrhythmia * 1  1/4681 (0.02%) 
Coronary artery disease * 1  1/4681 (0.02%) 
Palpitations * 1  1/4681 (0.02%) 
Sinus tachycardia * 1  1/4681 (0.02%) 
Congenital, familial and genetic disorders   
Chondrodystrophy * 1  1/4681 (0.02%) 
Factor V deficiency * 1  1/4681 (0.02%) 
Ear and labyrinth disorders   
Sudden hearing loss * 1  1/4681 (0.02%) 
Eye disorders   
Conjunctivitis * 1  1/4681 (0.02%) 
Visual disturbance * 1  1/4681 (0.02%) 
Gastrointestinal disorders   
Nausea * 1  3/4681 (0.06%) 
Pancreatitis * 1  2/4681 (0.04%) 
Tooth loss * 1  2/4681 (0.04%) 
Diarrhoea * 1  1/4681 (0.02%) 
Diverticular perforation * 1  1/4681 (0.02%) 
Diverticulum intestinal * 1  1/4681 (0.02%) 
Duodenitis * 1  1/4681 (0.02%) 
Dysphagia * 1  1/4681 (0.02%) 
Gastric haemorrhage * 1  1/4681 (0.02%) 
Gastritis erosive * 1  1/4681 (0.02%) 
Gastrointestinal mucosal disorder * 1  1/4681 (0.02%) 
Gastrointestinal pain * 1  1/4681 (0.02%) 
Haematochezia * 1  1/4681 (0.02%) 
Melaena * 1  1/4681 (0.02%) 
Pancreatic mass * 1  1/4681 (0.02%) 
Pancreatitis acute * 1  1/4681 (0.02%) 
Periodontitis * 1  1/4681 (0.02%) 
Peritoneal adhesions * 1  1/4681 (0.02%) 
Subileus * 1  1/4681 (0.02%) 
Vomiting * 1  1/4681 (0.02%) 
General disorders   
Pyrexia * 1  4/4681 (0.09%) 
Abasia * 1  1/4681 (0.02%) 
Adhesion * 1  1/4681 (0.02%) 
Chest discomfort * 1  1/4681 (0.02%) 
Chest pain * 1  1/4681 (0.02%) 
Disease recurrence * 1  1/4681 (0.02%) 
Pain * 1  1/4681 (0.02%) 
Performance status decreased * 1  1/4681 (0.02%) 
Death * 1  2/4681 (0.04%) 
Hepatobiliary disorders   
Cholelithiasis * 1  3/4681 (0.06%) 
Cholecystitis * 1  1/4681 (0.02%) 
Hepatocellular damage * 1  1/4681 (0.02%) 
Infections and infestations   
Pneumonia * 1  5/4681 (0.11%) 
Cellulitis * 1  3/4681 (0.06%) 
Acute tonsillitis * 1  2/4681 (0.04%) 
Tuberculosis * 1  2/4681 (0.04%) 
Urinary tract infection * 1  2/4681 (0.04%) 
Abscess limb * 1  1/4681 (0.02%) 
Anal abscess * 1  1/4681 (0.02%) 
Arthritis bacterial * 1  1/4681 (0.02%) 
Bronchitis * 1  1/4681 (0.02%) 
Cytomegalovirus infection * 1  1/4681 (0.02%) 
Fungal oesophagitis * 1  1/4681 (0.02%) 
Gastroenteritis escherichia coli * 1  1/4681 (0.02%) 
Gastrointestinal infection * 1  1/4681 (0.02%) 
Herpes zoster * 1  1/4681 (0.02%) 
Influenza * 1  1/4681 (0.02%) 
Pancreatitis bacterial * 1  1/4681 (0.02%) 
Peritonsillar abscess * 1  1/4681 (0.02%) 
Postoperative wound infection * 1  1/4681 (0.02%) 
Pulmonary tuberculosis * 1  1/4681 (0.02%) 
Respiratory tract infection * 1  1/4681 (0.02%) 
Salmonellosis * 1  1/4681 (0.02%) 
Sepsis * 1  1/4681 (0.02%) 
Sinusitis * 1  1/4681 (0.02%) 
Stitch abscess * 1  1/4681 (0.02%) 
Systemic mycosis * 1  1/4681 (0.02%) 
Injury, poisoning and procedural complications   
Fall * 1  3/4681 (0.06%) 
Cervical vertebral fracture * 1  2/4681 (0.04%) 
Post procedural complication * 1  2/4681 (0.04%) 
Accident * 1  1/4681 (0.02%) 
Ankle fracture * 1  1/4681 (0.02%) 
Dislocation of vertebra * 1  1/4681 (0.02%) 
Foot fracture * 1  1/4681 (0.02%) 
Haemothorax * 1  1/4681 (0.02%) 
Incisional hernia, obstructive * 1  1/4681 (0.02%) 
Lower limb fracture * 1  1/4681 (0.02%) 
Lumbar vertebral fracture * 1  1/4681 (0.02%) 
Meniscus lesion * 1  1/4681 (0.02%) 
Multiple injuries * 1  1/4681 (0.02%) 
Post procedural fistula * 1  1/4681 (0.02%) 
Road traffic accident * 1  1/4681 (0.02%) 
Spinal fracture * 1  1/4681 (0.02%) 
Thoracic vertebral fracture * 1  1/4681 (0.02%) 
Ureteric injury * 1  1/4681 (0.02%) 
Investigations   
Body temperature increased * 1  1/4681 (0.02%) 
Hepatic enzyme increased * 1  1/4681 (0.02%) 
Laboratory test abnormal * 1  1/4681 (0.02%) 
Laparoscopy * 1  1/4681 (0.02%) 
Weight decreased * 1  1/4681 (0.02%) 
Musculoskeletal and connective tissue disorders   
Ankylosing spondylitis * 1  5/4681 (0.11%) 
Musculoskeletal discomfort * 1  2/4681 (0.04%) 
Osteoarthritis * 1  2/4681 (0.04%) 
Arthralgia * 1  1/4681 (0.02%) 
Arthritis * 1  1/4681 (0.02%) 
Back pain * 1  1/4681 (0.02%) 
Intervertebral disc degeneration * 1  1/4681 (0.02%) 
Musculoskeletal pain * 1  1/4681 (0.02%) 
Myositis * 1  1/4681 (0.02%) 
Osteitis * 1  1/4681 (0.02%) 
Polyarthritis * 1  1/4681 (0.02%) 
Rotator cuff syndrome * 1  1/4681 (0.02%) 
Toe deformity * 1  1/4681 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer female * 1  1/4681 (0.02%) 
Colon cancer * 1  1/4681 (0.02%) 
Papillary thyroid cancer * 1  1/4681 (0.02%) 
Seminoma * 1  1/4681 (0.02%) 
Nervous system disorders   
Dizziness * 1  3/4681 (0.06%) 
Cerebrovascular accident * 1  2/4681 (0.04%) 
Hypoaesthesia * 1  2/4681 (0.04%) 
Transient ischaemic attack * 1  2/4681 (0.04%) 
Altered state of consciousness * 1  1/4681 (0.02%) 
Aphasia * 1  1/4681 (0.02%) 
Convulsion * 1  1/4681 (0.02%) 
Disturbance in attention * 1  1/4681 (0.02%) 
Hemiparesis * 1  1/4681 (0.02%) 
Hyperaesthesia * 1  1/4681 (0.02%) 
Multiple sclerosis * 1  1/4681 (0.02%) 
Polyneuropathy * 1  1/4681 (0.02%) 
Sciatica * 1  1/4681 (0.02%) 
Somnolence * 1  1/4681 (0.02%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/4681 (0.02%) 
Pregnancy * 1  1/4681 (0.02%) 
Psychiatric disorders   
Depression * 1  2/4681 (0.04%) 
Mental disorder * 1  1/4681 (0.02%) 
Panic disorder with agoraphobia * 1  1/4681 (0.02%) 
Suicidal ideation * 1  1/4681 (0.02%) 
Renal and urinary disorders   
Renal colic * 1  2/4681 (0.04%) 
Nephrolithiasis * 1  1/4681 (0.02%) 
Reproductive system and breast disorders   
Adnexa uteri cyst * 1  1/4681 (0.02%) 
Breast mass * 1  1/4681 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Nasal congestion * 1  1/4681 (0.02%) 
Nasal turbinate hypertrophy * 1  1/4681 (0.02%) 
Pulmonary embolism * 1  1/4681 (0.02%) 
Pulmonary fibrosis * 1  1/4681 (0.02%) 
Respiratory distress * 1  1/4681 (0.02%) 
Skin and subcutaneous tissue disorders   
Psoriasis * 1  2/4681 (0.04%) 
Alopecia * 1  1/4681 (0.02%) 
Dermatitis allergic * 1  1/4681 (0.02%) 
Dry skin * 1  1/4681 (0.02%) 
Erythema * 1  1/4681 (0.02%) 
Hyperhidrosis * 1  1/4681 (0.02%) 
Plantar erythema * 1  1/4681 (0.02%) 
Pruritus * 1  1/4681 (0.02%) 
Pustular psoriasis * 1  1/4681 (0.02%) 
Rash * 1  1/4681 (0.02%) 
Surgical and medical procedures   
Hospitalization * 1  10/4681 (0.21%) 
Hip arthroplasty * 1  4/4681 (0.09%) 
Knee arthroplasty * 1  3/4681 (0.06%) 
Intervertebral disc operation * 1  2/4681 (0.04%) 
Surgery * 1  2/4681 (0.04%) 
Vascular bypass graft * 1  2/4681 (0.04%) 
Adhesiolysis * 1  1/4681 (0.02%) 
Caecum operation * 1  1/4681 (0.02%) 
Cardioversion * 1  1/4681 (0.02%) 
Cholecystectomy * 1  1/4681 (0.02%) 
Coronary revascularization * 1  1/4681 (0.02%) 
Foot operation * 1  1/4681 (0.02%) 
Gastric operation * 1  1/4681 (0.02%) 
Hernia repair * 1  1/4681 (0.02%) 
Hysterectomy * 1  1/4681 (0.02%) 
Kidney ablation * 1  1/4681 (0.02%) 
Meniscus operation * 1  1/4681 (0.02%) 
Rehabilitation therapy * 1  1/4681 (0.02%) 
Salpingo-oophorectomy bilateral * 1  1/4681 (0.02%) 
Shoulder operation * 1  1/4681 (0.02%) 
Spinal operation * 1  1/4681 (0.02%) 
Stent placement * 1  1/4681 (0.02%) 
Therapeutic procedure * 1  1/4681 (0.02%) 
Tonsillectomy * 1  1/4681 (0.02%) 
Vascular disorders   
Hypertension * 1  2/4681 (0.04%) 
Aortic aneurysm * 1  1/4681 (0.02%) 
Deep vein thrombosis * 1  1/4681 (0.02%) 
Hypertensive crisis * 1  1/4681 (0.02%) 
Thrombosis * 1  1/4681 (0.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ankylosing Spondylitis
Affected / at Risk (%)
Total   1099/4681 (23.48%) 
Blood and lymphatic system disorders   
Lymphadenopathy * 1  5/4681 (0.11%) 
Leukopenia * 1  2/4681 (0.04%) 
Anaemia * 1  1/4681 (0.02%) 
Anaemia neonatal * 1  1/4681 (0.02%) 
Haemolysis * 1  1/4681 (0.02%) 
Haemolysis neonatal * 1  1/4681 (0.02%) 
Lymphatic disorder * 1  1/4681 (0.02%) 
Neutropenia * 1  1/4681 (0.02%) 
Platelet disorder * 1  1/4681 (0.02%) 
Cardiac disorders   
Arrhythmia * 1  3/4681 (0.06%) 
Palpitations * 1  3/4681 (0.06%) 
Pericarditis * 1  3/4681 (0.06%) 
Tachycardia * 1  3/4681 (0.06%) 
Cardiac failure * 1  2/4681 (0.04%) 
Cardiovascular disorder * 1  2/4681 (0.04%) 
Coronary artery disease * 1  2/4681 (0.04%) 
Angina pectoris * 1  1/4681 (0.02%) 
Aortic valve incompetence * 1  1/4681 (0.02%) 
Arrhythmia supraventricular * 1  1/4681 (0.02%) 
Cardiomegaly * 1  1/4681 (0.02%) 
Mitral valve incompetence * 1  1/4681 (0.02%) 
Pericardial effusion * 1  1/4681 (0.02%) 
Congenital, familial and genetic disorders   
Dermoid cyst * 1  1/4681 (0.02%) 
Ear and labyrinth disorders   
Tinnitus * 1  3/4681 (0.06%) 
Deafness unilateral * 1  1/4681 (0.02%) 
Ear pain * 1  1/4681 (0.02%) 
Middle ear inflammation * 1  1/4681 (0.02%) 
Sudden hearing loss * 1  1/4681 (0.02%) 
Endocrine disorders   
Hypothyroidism * 1  1/4681 (0.02%) 
Eye disorders   
Visual disturbance * 1  10/4681 (0.21%) 
Iritis * 1  7/4681 (0.15%) 
Eye pain * 1  4/4681 (0.09%) 
Dry eye * 1  3/4681 (0.06%) 
Uveitis * 1  3/4681 (0.06%) 
Conjunctivitis * 1  2/4681 (0.04%) 
Eye inflammation * 1  2/4681 (0.04%) 
Eye pruritus * 1  2/4681 (0.04%) 
Iridocyclitis * 1  2/4681 (0.04%) 
Ocular hyperaemia * 1  2/4681 (0.04%) 
Blepharospasm * 1  1/4681 (0.02%) 
Cataract * 1  1/4681 (0.02%) 
Chalazion * 1  1/4681 (0.02%) 
Conjunctival hyperaemia * 1  1/4681 (0.02%) 
Diplopia * 1  1/4681 (0.02%) 
Glaucoma * 1  1/4681 (0.02%) 
Myopia * 1  1/4681 (0.02%) 
Ocular discomfort * 1  1/4681 (0.02%) 
Sicca syndrome * 1  1/4681 (0.02%) 
Ulcerative keratitis * 1  1/4681 (0.02%) 
Visual acuity reduced * 1  1/4681 (0.02%) 
Gastrointestinal disorders   
Diarrhoea * 1  23/4681 (0.49%) 
Nausea * 1  17/4681 (0.36%) 
Periodontitis * 1  7/4681 (0.15%) 
Abdominal pain upper * 1  5/4681 (0.11%) 
Gastrointestinal pain * 1  5/4681 (0.11%) 
Vomiting * 1  5/4681 (0.11%) 
Gastritis * 1  4/4681 (0.09%) 
Tooth disorder * 1  4/4681 (0.09%) 
Abdominal discomfort * 1  3/4681 (0.06%) 
Abdominal pain * 1  3/4681 (0.06%) 
Abdominal pain lower * 1  3/4681 (0.06%) 
Colitis * 1  3/4681 (0.06%) 
Abdominal distension * 1  2/4681 (0.04%) 
Aphthous stomatitis * 1  2/4681 (0.04%) 
Dental caries * 1  2/4681 (0.04%) 
Dyspepsia * 1  2/4681 (0.04%) 
Dysphagia * 1  2/4681 (0.04%) 
Gingival bleeding * 1  2/4681 (0.04%) 
Haematochezia * 1  2/4681 (0.04%) 
Hypoaesthesia oral * 1  2/4681 (0.04%) 
Oral discomfort * 1  2/4681 (0.04%) 
Reflux oesophagitis * 1  2/4681 (0.04%) 
Stomatitis * 1  2/4681 (0.04%) 
Anal fissure * 1  1/4681 (0.02%) 
Ascites * 1  1/4681 (0.02%) 
Crohn's disease * 1  1/4681 (0.02%) 
Diverticulum * 1  1/4681 (0.02%) 
Dry mouth * 1  1/4681 (0.02%) 
Frequent bowel movements * 1  1/4681 (0.02%) 
Gastric ulcer * 1  1/4681 (0.02%) 
Gastroduodenitis * 1  1/4681 (0.02%) 
Glossodynia * 1  1/4681 (0.02%) 
Haemorrhoids * 1  1/4681 (0.02%) 
Hiatus hernia * 1  1/4681 (0.02%) 
Intestinal haemorrhage * 1  1/4681 (0.02%) 
Lip blister * 1  1/4681 (0.02%) 
Odynophagia * 1  1/4681 (0.02%) 
Oedema mouth * 1  1/4681 (0.02%) 
Oral mucosal blistering * 1  1/4681 (0.02%) 
Oral mucosal disorder * 1  1/4681 (0.02%) 
Proctitis * 1  1/4681 (0.02%) 
Retching * 1  1/4681 (0.02%) 
Salivary gland disorder * 1  1/4681 (0.02%) 
Stomach discomfort * 1  1/4681 (0.02%) 
Tongue black hairy * 1  1/4681 (0.02%) 
Toothache * 1  1/4681 (0.02%) 
General disorders   
Drug ineffective * 1  210/4681 (4.49%) 
Influenza like illness * 1  50/4681 (1.07%) 
Pyrexia * 1  33/4681 (0.70%) 
Injection site erythema * 1  32/4681 (0.68%) 
Fatigue * 1  27/4681 (0.58%) 
Injection site pruritus * 1  15/4681 (0.32%) 
Injection site irritation * 1  12/4681 (0.26%) 
Injection site reaction * 1  12/4681 (0.26%) 
Oedema peripheral * 1  10/4681 (0.21%) 
Injection site pain * 1  8/4681 (0.17%) 
Injection site swelling * 1  8/4681 (0.17%) 
Impaired healing * 1  7/4681 (0.15%) 
Drug intolerance * 1  5/4681 (0.11%) 
Malaise * 1  5/4681 (0.11%) 
Pain * 1  5/4681 (0.11%) 
Chills * 1  4/4681 (0.09%) 
General physical health deterioration * 1  4/4681 (0.09%) 
Inflammation * 1  4/4681 (0.09%) 
Asthenia * 1  2/4681 (0.04%) 
Chest discomfort * 1  2/4681 (0.04%) 
Chest pain * 1  2/4681 (0.04%) 
Condition aggravated * 1  2/4681 (0.04%) 
Injection site rash * 1  2/4681 (0.04%) 
Injection site warmth * 1  2/4681 (0.04%) 
Local swelling * 1  2/4681 (0.04%) 
Mucosal dryness * 1  2/4681 (0.04%) 
Sensation of foreign body * 1  2/4681 (0.04%) 
Swelling * 1  2/4681 (0.04%) 
Abasia * 1  1/4681 (0.02%) 
Adverse event * 1  1/4681 (0.02%) 
Cyst * 1  1/4681 (0.02%) 
Feeling abnormal * 1  1/4681 (0.02%) 
Feeling cold * 1  1/4681 (0.02%) 
Feeling hot * 1  1/4681 (0.02%) 
Gait disturbance * 1  1/4681 (0.02%) 
Induration * 1  1/4681 (0.02%) 
Injection site discharge * 1  1/4681 (0.02%) 
Injection site induration * 1  1/4681 (0.02%) 
Injection site inflammation * 1  1/4681 (0.02%) 
Injection site urticaria * 1  1/4681 (0.02%) 
Mucosal haemorrhage * 1  1/4681 (0.02%) 
Mucosal inflammation * 1  1/4681 (0.02%) 
Performance status decreased * 1  1/4681 (0.02%) 
Tenderness * 1  1/4681 (0.02%) 
Hepatobiliary disorders   
Cholelithiasis * 1  2/4681 (0.04%) 
Liver disorder * 1  2/4681 (0.04%) 
Biliary colic * 1  1/4681 (0.02%) 
Cholecystitis * 1  1/4681 (0.02%) 
Gallbladder polyp * 1  1/4681 (0.02%) 
Hepatitis * 1  1/4681 (0.02%) 
Hepatomegaly * 1  1/4681 (0.02%) 
Hyperbilirubinaemia neonatal * 1  1/4681 (0.02%) 
Immune system disorders   
Hypersensitivity * 1  6/4681 (0.13%) 
Anaphylactic reaction * 1  2/4681 (0.04%) 
Infections and infestations   
Bronchitis * 1  46/4681 (0.98%) 
Upper respiratory tract infection * 1  46/4681 (0.98%) 
Nasopharyngitis * 1  37/4681 (0.79%) 
Infection * 1  36/4681 (0.77%) 
Sinusitis * 1  33/4681 (0.70%) 
Respiratory tract infection * 1  24/4681 (0.51%) 
Herpes zoster * 1  15/4681 (0.32%) 
Gastrointestinal infection * 1  12/4681 (0.26%) 
Infection in an immunocompromised host * 1  12/4681 (0.26%) 
Rash pustular * 1  11/4681 (0.23%) 
Otitis media * 1  10/4681 (0.21%) 
Pneumonia * 1  10/4681 (0.21%) 
Urinary tract infection * 1  10/4681 (0.21%) 
Acute tonsillitis * 1  9/4681 (0.19%) 
Cystitis * 1  9/4681 (0.19%) 
Oral herpes * 1  9/4681 (0.19%) 
Rhinitis * 1  6/4681 (0.13%) 
Tonsillitis * 1  6/4681 (0.13%) 
Erysipelas * 1  4/4681 (0.09%) 
Folliculitis * 1  4/4681 (0.09%) 
Furuncle * 1  4/4681 (0.09%) 
Herpes virus infection * 1  4/4681 (0.09%) 
Laryngitis * 1  4/4681 (0.09%) 
Pharyngitis * 1  4/4681 (0.09%) 
Pyelonephritis * 1  4/4681 (0.09%) 
Influenza * 1  3/4681 (0.06%) 
Viral infection * 1  3/4681 (0.06%) 
Vulvovaginal mycotic infection * 1  3/4681 (0.06%) 
Abscess * 1  2/4681 (0.04%) 
Bronchopneumonia * 1  2/4681 (0.04%) 
Chronic sinusitis * 1  2/4681 (0.04%) 
Diverticulitis * 1  2/4681 (0.04%) 
Ear infection * 1  2/4681 (0.04%) 
Gastroenteritis * 1  2/4681 (0.04%) 
Paronychia * 1  2/4681 (0.04%) 
Respiratory tract infection viral * 1  2/4681 (0.04%) 
Skin infection * 1  2/4681 (0.04%) 
Tooth infection * 1  2/4681 (0.04%) 
Abdominal wall abscess * 1  1/4681 (0.02%) 
Abscess jaw * 1  1/4681 (0.02%) 
Anal abscess * 1  1/4681 (0.02%) 
Anogenital warts * 1  1/4681 (0.02%) 
Body tinea * 1  1/4681 (0.02%) 
Borrelia infection * 1  1/4681 (0.02%) 
Bronchitis bacterial * 1  1/4681 (0.02%) 
Campylobacter intestinal infection * 1  1/4681 (0.02%) 
Conjunctivitis infective * 1  1/4681 (0.02%) 
Eczema impetiginous * 1  1/4681 (0.02%) 
Erythema infectiosum * 1  1/4681 (0.02%) 
Fungal skin infection * 1  1/4681 (0.02%) 
Gastrointestinal fungal infection * 1  1/4681 (0.02%) 
Genital abscess * 1  1/4681 (0.02%) 
Genitourinary tract infection * 1  1/4681 (0.02%) 
Gingival infection * 1  1/4681 (0.02%) 
Groin abscess * 1  1/4681 (0.02%) 
Infectious mononucleosis * 1  1/4681 (0.02%) 
Intervertebral discitis * 1  1/4681 (0.02%) 
Latent tuberculosis * 1  1/4681 (0.02%) 
Legionella infection * 1  1/4681 (0.02%) 
Molluscum contagiosum * 1  1/4681 (0.02%) 
Onychomycosis * 1  1/4681 (0.02%) 
Oropharyngitis fungal * 1  1/4681 (0.02%) 
Parotitis * 1  1/4681 (0.02%) 
Pertussis * 1  1/4681 (0.02%) 
Postoperative wound infection * 1  1/4681 (0.02%) 
Pseudofolliculitis barbae * 1  1/4681 (0.02%) 
Puncture site abscess * 1  1/4681 (0.02%) 
Scarlet fever * 1  1/4681 (0.02%) 
Sepsis * 1  1/4681 (0.02%) 
Sialoadenitis * 1  1/4681 (0.02%) 
Subcutaneous abscess * 1  1/4681 (0.02%) 
Tinea infection * 1  1/4681 (0.02%) 
Tinea pedis * 1  1/4681 (0.02%) 
Tooth abscess * 1  1/4681 (0.02%) 
Urosepsis * 1  1/4681 (0.02%) 
Vaginal abscess * 1  1/4681 (0.02%) 
Varicella * 1  1/4681 (0.02%) 
Viral upper respiratory tract infection * 1  1/4681 (0.02%) 
Injury, poisoning and procedural complications   
Accident * 1  3/4681 (0.06%) 
Tendon rupture * 1  3/4681 (0.06%) 
Accident at work * 1  2/4681 (0.04%) 
Clavicle fracture * 1  2/4681 (0.04%) 
Fall * 1  2/4681 (0.04%) 
Limb traumatic amputation * 1  2/4681 (0.04%) 
Lower limb fracture * 1  2/4681 (0.04%) 
Muscle injury * 1  2/4681 (0.04%) 
Ankle fracture * 1  1/4681 (0.02%) 
Arthropod bite * 1  1/4681 (0.02%) 
Contusion * 1  1/4681 (0.02%) 
Epicondylitis * 1  1/4681 (0.02%) 
Excoriation * 1  1/4681 (0.02%) 
Fibula fracture * 1  1/4681 (0.02%) 
Forearm fracture * 1  1/4681 (0.02%) 
Fracture * 1  1/4681 (0.02%) 
Hand fracture * 1  1/4681 (0.02%) 
Joint sprain * 1  1/4681 (0.02%) 
Lumbar vertebral fracture * 1  1/4681 (0.02%) 
Open fracture * 1  1/4681 (0.02%) 
Post procedural complication * 1  1/4681 (0.02%) 
Rib fracture * 1  1/4681 (0.02%) 
Skeletal injury * 1  1/4681 (0.02%) 
Skin injury * 1  1/4681 (0.02%) 
Skin laceration * 1  1/4681 (0.02%) 
Tendon injury * 1  1/4681 (0.02%) 
Thoracic vertebral fracture * 1  1/4681 (0.02%) 
Traumatic brain injury * 1  1/4681 (0.02%) 
Wrist fracture * 1  1/4681 (0.02%) 
Investigations   
Hepatic enzyme increased * 1  16/4681 (0.34%) 
Weight decreased * 1  11/4681 (0.23%) 
Transaminases increased * 1  9/4681 (0.19%) 
Alanine aminotransferase increased * 1  8/4681 (0.17%) 
Weight increased * 1  8/4681 (0.17%) 
Gamma-glutamyltransferase increased * 1  4/4681 (0.09%) 
Arthroscopy * 1  3/4681 (0.06%) 
Aspartate aminotransferase increased * 1  3/4681 (0.06%) 
Blood pressure increased * 1  3/4681 (0.06%) 
C-reactive protein increased * 1  2/4681 (0.04%) 
Antinuclear antibody increased * 1  1/4681 (0.02%) 
Biopsy breast normal * 1  1/4681 (0.02%) 
Blood count abnormal * 1  1/4681 (0.02%) 
Blood creatine phosphokinase increased * 1  1/4681 (0.02%) 
Blood testosterone decreased * 1  1/4681 (0.02%) 
Blood urine present * 1  1/4681 (0.02%) 
Borrelia burgdorferi serology positive * 1  1/4681 (0.02%) 
Computerised tomogram thorax abnormal * 1  1/4681 (0.02%) 
Double stranded DNA antibody * 1  1/4681 (0.02%) 
Endoscopic retrograde cholangiopancreatography * 1  1/4681 (0.02%) 
Haematology test * 1  1/4681 (0.02%) 
Haemoglobin decreased * 1  1/4681 (0.02%) 
Hysteroscopy * 1  1/4681 (0.02%) 
Laboratory test abnormal * 1  1/4681 (0.02%) 
Lipase increased * 1  1/4681 (0.02%) 
Prostatic specific antigen increased * 1  1/4681 (0.02%) 
Prothrombin time shortened * 1  1/4681 (0.02%) 
Red blood cell sedimentation rate increased * 1  1/4681 (0.02%) 
Metabolism and nutrition disorders   
Anorexia * 1  1/4681 (0.02%) 
Diabetes mellitus * 1  1/4681 (0.02%) 
Gout * 1  1/4681 (0.02%) 
Iron deficiency * 1  1/4681 (0.02%) 
Metabolic syndrome * 1  1/4681 (0.02%) 
Podagra * 1  1/4681 (0.02%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion * 1  10/4681 (0.21%) 
Myalgia * 1  7/4681 (0.15%) 
Arthralgia * 1  6/4681 (0.13%) 
Back pain * 1  6/4681 (0.13%) 
Pain in extremity * 1  6/4681 (0.13%) 
Arthritis * 1  4/4681 (0.09%) 
Musculoskeletal pain * 1  4/4681 (0.09%) 
Osteoarthritis * 1  4/4681 (0.09%) 
Limb discomfort * 1  3/4681 (0.06%) 
Lupus-like syndrome * 1  3/4681 (0.06%) 
Muscle spasms * 1  3/4681 (0.06%) 
Musculoskeletal discomfort * 1  3/4681 (0.06%) 
Musculoskeletal stiffness * 1  3/4681 (0.06%) 
Osteitis * 1  3/4681 (0.06%) 
Bone pain * 1  2/4681 (0.04%) 
Myofascial pain syndrome * 1  2/4681 (0.04%) 
Tendonitis * 1  2/4681 (0.04%) 
Tenosynovitis * 1  2/4681 (0.04%) 
Toe deformity * 1  2/4681 (0.04%) 
Ankylosing spondylitis * 1  1/4681 (0.02%) 
Bone disorder * 1  1/4681 (0.02%) 
Bursitis * 1  1/4681 (0.02%) 
Fibromyalgia * 1  1/4681 (0.02%) 
Fistula * 1  1/4681 (0.02%) 
Flank pain * 1  1/4681 (0.02%) 
Groin pain * 1  1/4681 (0.02%) 
Joint swelling * 1  1/4681 (0.02%) 
Muscle tightness * 1  1/4681 (0.02%) 
Muscular weakness * 1  1/4681 (0.02%) 
Neck pain * 1  1/4681 (0.02%) 
Osteoporosis * 1  1/4681 (0.02%) 
Plantar fasciitis * 1  1/4681 (0.02%) 
Sensation of heaviness * 1  1/4681 (0.02%) 
Synovial cyst * 1  1/4681 (0.02%) 
Tenosynovitis stenosans * 1  1/4681 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer female * 1  2/4681 (0.04%) 
Seminoma * 1  2/4681 (0.04%) 
Benign breast neoplasm * 1  1/4681 (0.02%) 
Breast neoplasm * 1  1/4681 (0.02%) 
Laryngeal cancer * 1  1/4681 (0.02%) 
Lung neoplasm * 1  1/4681 (0.02%) 
Metastases to bone * 1  1/4681 (0.02%) 
Prostate cancer * 1  1/4681 (0.02%) 
Rectal cancer * 1  1/4681 (0.02%) 
Testis cancer * 1  1/4681 (0.02%) 
Xanthoma * 1  1/4681 (0.02%) 
Nervous system disorders   
Headache * 1  37/4681 (0.79%) 
Dizziness * 1  19/4681 (0.41%) 
Paraesthesia * 1  10/4681 (0.21%) 
Carpal tunnel syndrome * 1  4/4681 (0.09%) 
Hypoaesthesia * 1  4/4681 (0.09%) 
Disturbance in attention * 1  3/4681 (0.06%) 
Dysgeusia * 1  3/4681 (0.06%) 
Syncope * 1  3/4681 (0.06%) 
Burning sensation * 1  2/4681 (0.04%) 
Migraine * 1  2/4681 (0.04%) 
Multiple sclerosis * 1  2/4681 (0.04%) 
Sensory disturbance * 1  2/4681 (0.04%) 
Ageusia * 1  1/4681 (0.02%) 
Aphasia * 1  1/4681 (0.02%) 
Aphonia * 1  1/4681 (0.02%) 
Arachnoid cyst * 1  1/4681 (0.02%) 
Autonomic nervous system imbalance * 1  1/4681 (0.02%) 
Balance disorder * 1  1/4681 (0.02%) 
Cluster headache * 1  1/4681 (0.02%) 
Dysaesthesia * 1  1/4681 (0.02%) 
Hemiparesis * 1  1/4681 (0.02%) 
Hyperaesthesia * 1  1/4681 (0.02%) 
Hypotonia * 1  1/4681 (0.02%) 
Memory impairment * 1  1/4681 (0.02%) 
Movement disorder * 1  1/4681 (0.02%) 
Neurological symptom * 1  1/4681 (0.02%) 
Paralysis * 1  1/4681 (0.02%) 
Psychomotor hyperactivity * 1  1/4681 (0.02%) 
Somnolence * 1  1/4681 (0.02%) 
Tension headache * 1  1/4681 (0.02%) 
Tremor * 1  1/4681 (0.02%) 
Ulnar tunnel syndrome * 1  1/4681 (0.02%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  21/4681 (0.45%) 
Psychiatric disorders   
Depression * 1  8/4681 (0.17%) 
Depressed mood * 1  7/4681 (0.15%) 
Sleep disorder * 1  6/4681 (0.13%) 
Insomnia * 1  3/4681 (0.06%) 
Loss of libido * 1  3/4681 (0.06%) 
Agitation * 1  2/4681 (0.04%) 
Anxiety * 1  2/4681 (0.04%) 
Emotional distress * 1  2/4681 (0.04%) 
Restlessness * 1  2/4681 (0.04%) 
Somatisation disorder * 1  2/4681 (0.04%) 
Binge eating * 1  1/4681 (0.02%) 
Confusional state * 1  1/4681 (0.02%) 
Mental disorder * 1  1/4681 (0.02%) 
Nervousness * 1  1/4681 (0.02%) 
Panic disorder * 1  1/4681 (0.02%) 
Psychosomatic disease * 1  1/4681 (0.02%) 
Somatoform disorder * 1  1/4681 (0.02%) 
Renal and urinary disorders   
Haematuria * 1  2/4681 (0.04%) 
Leukocyturia * 1  2/4681 (0.04%) 
Renal colic * 1  2/4681 (0.04%) 
Calculus ureteric * 1  1/4681 (0.02%) 
Dysuria * 1  1/4681 (0.02%) 
Nocturia * 1  1/4681 (0.02%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  6/4681 (0.13%) 
Menorrhagia * 1  2/4681 (0.04%) 
Prostatitis * 1  2/4681 (0.04%) 
Breast cyst * 1  1/4681 (0.02%) 
Endometrial hyperplasia * 1  1/4681 (0.02%) 
Hypomenorrhoea * 1  1/4681 (0.02%) 
Menstruation irregular * 1  1/4681 (0.02%) 
Metrorrhagia * 1  1/4681 (0.02%) 
Orchitis noninfective * 1  1/4681 (0.02%) 
Prostatic disorder * 1  1/4681 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  17/4681 (0.36%) 
Pharyngolaryngeal pain * 1  6/4681 (0.13%) 
Dyspnoea * 1  5/4681 (0.11%) 
Asthma * 1  4/4681 (0.09%) 
Respiratory distress * 1  4/4681 (0.09%) 
Dysphonia * 1  3/4681 (0.06%) 
Throat irritation * 1  3/4681 (0.06%) 
Tonsillar inflammation * 1  3/4681 (0.06%) 
Productive cough * 1  2/4681 (0.04%) 
Rhinorrhoea * 1  2/4681 (0.04%) 
Sleep apnoea syndrome * 1  2/4681 (0.04%) 
Bronchitis chronic * 1  1/4681 (0.02%) 
Dyspnoea exertional * 1  1/4681 (0.02%) 
Epistaxis * 1  1/4681 (0.02%) 
Increased upper airway secretion * 1  1/4681 (0.02%) 
Nasal discomfort * 1  1/4681 (0.02%) 
Pharyngeal inflammation * 1  1/4681 (0.02%) 
Respiratory disorder * 1  1/4681 (0.02%) 
Sneezing * 1  1/4681 (0.02%) 
Snoring * 1  1/4681 (0.02%) 
Skin and subcutaneous tissue disorders   
Rash * 1  35/4681 (0.75%) 
Psoriasis * 1  30/4681 (0.64%) 
Pruritus * 1  26/4681 (0.56%) 
Pustular psoriasis * 1  19/4681 (0.41%) 
Erythema * 1  18/4681 (0.38%) 
Alopecia * 1  13/4681 (0.28%) 
Dermatitis allergic * 1  12/4681 (0.26%) 
Urticaria * 1  9/4681 (0.19%) 
Hyperhidrosis * 1  8/4681 (0.17%) 
Night sweats * 1  7/4681 (0.15%) 
Skin exfoliation * 1  7/4681 (0.15%) 
Acne * 1  5/4681 (0.11%) 
Dry skin * 1  5/4681 (0.11%) 
Eczema * 1  5/4681 (0.11%) 
Pruritus generalised * 1  5/4681 (0.11%) 
Rash papular * 1  5/4681 (0.11%) 
Skin reaction * 1  5/4681 (0.11%) 
Drug eruption * 1  4/4681 (0.09%) 
Rash generalised * 1  4/4681 (0.09%) 
Rash pruritic * 1  4/4681 (0.09%) 
Skin disorder * 1  4/4681 (0.09%) 
Blister * 1  3/4681 (0.06%) 
Erythema multiforme * 1  3/4681 (0.06%) 
Rash maculo-papular * 1  3/4681 (0.06%) 
Dermatitis * 1  2/4681 (0.04%) 
Dermatitis atopic * 1  2/4681 (0.04%) 
Dermatitis psoriasiform * 1  2/4681 (0.04%) 
Dyshidrosis * 1  2/4681 (0.04%) 
Neurodermatitis * 1  2/4681 (0.04%) 
Photosensitivity reaction * 1  2/4681 (0.04%) 
Acrodermatitis * 1  1/4681 (0.02%) 
Dermal cyst * 1  1/4681 (0.02%) 
Erythema annulare * 1  1/4681 (0.02%) 
Heat rash * 1  1/4681 (0.02%) 
Hypoaesthesia facial * 1  1/4681 (0.02%) 
Intertrigo * 1  1/4681 (0.02%) 
Nail bed inflammation * 1  1/4681 (0.02%) 
Onychoclasis * 1  1/4681 (0.02%) 
Onycholysis * 1  1/4681 (0.02%) 
Parapsoriasis * 1  1/4681 (0.02%) 
Pigmentation disorder * 1  1/4681 (0.02%) 
Pityriasis rosea * 1  1/4681 (0.02%) 
Rash erythematous * 1  1/4681 (0.02%) 
Rash macular * 1  1/4681 (0.02%) 
Rosacea * 1  1/4681 (0.02%) 
Seborrhoeic dermatitis * 1  1/4681 (0.02%) 
Skin burning sensation * 1  1/4681 (0.02%) 
Skin fibrosis * 1  1/4681 (0.02%) 
Skin lesion * 1  1/4681 (0.02%) 
Skin nodule * 1  1/4681 (0.02%) 
Skin odour abnormal * 1  1/4681 (0.02%) 
Skin swelling * 1  1/4681 (0.02%) 
Skin warm * 1  1/4681 (0.02%) 
Stasis dermatitis * 1  1/4681 (0.02%) 
Swelling face * 1  1/4681 (0.02%) 
Urticaria generalised * 1  1/4681 (0.02%) 
Social circumstances   
Pregnancy of partner * 1  4/4681 (0.09%) 
Miscarriage of partner * 1  1/4681 (0.02%) 
Surgical and medical procedures   
Hospitalisation * 1  8/4681 (0.17%) 
Dental operation * 1  5/4681 (0.11%) 
Hip arthroplasty * 1  5/4681 (0.11%) 
Antibiotic prophylaxis * 1  4/4681 (0.09%) 
Hip surgery * 1  4/4681 (0.09%) 
Surgery * 1  4/4681 (0.09%) 
Meniscus operation * 1  3/4681 (0.06%) 
Tonsillectomy * 1  3/4681 (0.06%) 
Arthrodesis * 1  2/4681 (0.04%) 
Dental treatment * 1  2/4681 (0.04%) 
Hysterectomy * 1  2/4681 (0.04%) 
Inguinal hernia repair * 1  2/4681 (0.04%) 
Knee operation * 1  2/4681 (0.04%) 
Nasal septal operation * 1  2/4681 (0.04%) 
Tendon operation * 1  2/4681 (0.04%) 
Tooth extraction * 1  2/4681 (0.04%) 
Allergenic desensitisation procedure * 1  1/4681 (0.02%) 
Anorectal operation * 1  1/4681 (0.02%) 
Aortic valve replacement * 1  1/4681 (0.02%) 
Appendicectomy * 1  1/4681 (0.02%) 
Arthroscopic surgery * 1  1/4681 (0.02%) 
Cervical conisation * 1  1/4681 (0.02%) 
Cholecystectomy * 1  1/4681 (0.02%) 
Chondroplasty * 1  1/4681 (0.02%) 
Coronary angioplasty * 1  1/4681 (0.02%) 
Coronary arterial stent insertion * 1  1/4681 (0.02%) 
Dental implantation * 1  1/4681 (0.02%) 
Eye laser surgery * 1  1/4681 (0.02%) 
Female genital operation * 1  1/4681 (0.02%) 
Haemorrhoid operation * 1  1/4681 (0.02%) 
Heart valve operation * 1  1/4681 (0.02%) 
Intervertebral disc operation * 1  1/4681 (0.02%) 
Intestinal operation * 1  1/4681 (0.02%) 
Joint irrigation * 1  1/4681 (0.02%) 
Knee arthroplasty * 1  1/4681 (0.02%) 
Large intestine operation * 1  1/4681 (0.02%) 
Laryngeal operation * 1  1/4681 (0.02%) 
Meniscus removal * 1  1/4681 (0.02%) 
Oophorectomy * 1  1/4681 (0.02%) 
Otorhinolaryngological surgery * 1  1/4681 (0.02%) 
Radiotherapy * 1  1/4681 (0.02%) 
Salpingectomy * 1  1/4681 (0.02%) 
Sigmoidectomy * 1  1/4681 (0.02%) 
Sinus operation * 1  1/4681 (0.02%) 
Skin operation * 1  1/4681 (0.02%) 
Spinal operation * 1  1/4681 (0.02%) 
Testicular operation * 1  1/4681 (0.02%) 
Toe operation * 1  1/4681 (0.02%) 
Uterine dilation and curettage * 1  1/4681 (0.02%) 
Vascular disorders   
Haematoma * 1  4/4681 (0.09%) 
Hypertension * 1  4/4681 (0.09%) 
Thrombosis * 1  4/4681 (0.09%) 
Lymphoedema * 1  3/4681 (0.06%) 
Hot flush * 1  2/4681 (0.04%) 
Blood pressure fluctuation * 1  1/4681 (0.02%) 
Flushing * 1  1/4681 (0.02%) 
Hypotension * 1  1/4681 (0.02%) 
Temporal arteritis * 1  1/4681 (0.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v 12.1
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01079182     History of Changes
Other Study ID Numbers: P10-147
First Submitted: March 1, 2010
First Posted: March 3, 2010
Results First Submitted: May 13, 2015
Results First Posted: June 1, 2015
Last Update Posted: July 9, 2015