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A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00853385
First received: February 27, 2009
Last updated: January 10, 2013
Last verified: January 2013
Results First Received: December 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: CP 690,550
Drug: CP-690,550
Other: Placebo
Biological: Biologic TNFi

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.

Participant Flow:   Overall Study
    CP-690,550 5 mg   CP-690,550 10 mg   Placebo, Then CP-690,550 5 mg   Placebo, Then CP-690,550 10 mg   Adalimumab
STARTED   204   201   56   52   204 
COMPLETED   150   158   47   39   162 
NOT COMPLETED   54   43   9   13   42 
Death                0                0                0                0                1 
Adverse Event                24                24                2                5                22 
Lack of Efficacy                6                7                3                3                6 
Lost to Follow-up                2                1                0                0                0 
Withdrawal by Subject                4                2                0                1                1 
Unspecified                18                9                4                4                12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Total Total of all reporting groups

Baseline Measures
   CP-690,550 5 mg   CP-690,550 10 mg   Placebo, Then CP-690,550 5 mg   Placebo, Then CP-690,550 10 mg   Adalimumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 204   201   56   52   204   717 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.0  (11.9)   52.9  (11.8)   55.5  (13.7)   51.9  (13.7)   52.5  (11.7)   52.9  (12.1) 
Gender 
[Units: Participants]
           
Female   174   168   43   39   162   586 
Male   30   33   13   13   42   131 


  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6   [ Time Frame: Month 6 ]

2.  Primary:   Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3   [ Time Frame: Baseline, Month 3 ]

3.  Primary:   Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6   [ Time Frame: Month 6 ]

4.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3   [ Time Frame: Month 1, 3 ]

5.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

6.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

7.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

8.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

9.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12   [ Time Frame: Month 9, 12 ]

10.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

11.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

12.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

13.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

14.  Secondary:   Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])   [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]

15.  Secondary:   Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])   [ Time Frame: Baseline, Month 1, 3, 6, 9, 12 ]

16.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6   [ Time Frame: Month 1, 3, 6 ]

17.  Secondary:   Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

18.  Secondary:   Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

19.  Secondary:   Patient Assessment of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

20.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

21.  Secondary:   Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

22.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

23.  Secondary:   Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12   [ Time Frame: Month 9, 12 ]

24.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

25.  Secondary:   36-Item Short-Form Health Survey (SF-36) at Month 9 and 12   [ Time Frame: Month 9, 12 ]

26.  Secondary:   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

27.  Secondary:   Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12   [ Time Frame: Month 12 ]

28.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

29.  Secondary:   Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12   [ Time Frame: Month 12 ]

30.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

31.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12   [ Time Frame: Month 12 ]

32.  Secondary:   Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6   [ Time Frame: Baseline, Month 1, 3, 6 ]

33.  Secondary:   Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12   [ Time Frame: Month 12 ]

34.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Month 3 and 6   [ Time Frame: Month 3, 6 ]

35.  Secondary:   Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12   [ Time Frame: Baseline, Month 12 ]

36.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

37.  Secondary:   Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12   [ Time Frame: Month 12 ]

38.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

39.  Secondary:   Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]

40.  Secondary:   Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

41.  Secondary:   Number of Days as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]

42.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

43.  Secondary:   Number of Hours Per Day as Assessed RA-HCRU at Month 12   [ Time Frame: Month 12 ]

44.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6   [ Time Frame: Baseline, Month 3, 6 ]

45.  Secondary:   Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Baseline Through Month 12
Additional 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 nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   2  

Reporting Groups
  Description
CP-690,550 5 mg (Up To Month 3) CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
CP-690,550 10 mg (Up To Month 3) CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
Placebo (Up To Month 3) Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab (Up To Month 3) Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
CP-690,550 5 mg (Month 3 to 6) CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
CP-690,550 10 mg (Month 3 to 6) CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
Placebo (Month 3 to 6) Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Adalimumab (Month 3 to 6) Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
CP-690,550 5 mg (Post Month 6) CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
CP-690,550 10 mg (Post Month 6) CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
Adalimumab (Post Month 6) Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.

Other Adverse Events
    CP-690,550 5 mg (Up To Month 3)   CP-690,550 10 mg (Up To Month 3)   Placebo (Up To Month 3)   Adalimumab (Up To Month 3)   CP-690,550 5 mg (Month 3 to 6)   CP-690,550 10 mg (Month 3 to 6)   Placebo (Month 3 to 6)   Adalimumab (Month 3 to 6)   CP-690,550 5 mg (Post Month 6)   CP-690,550 10 mg (Post Month 6)   Adalimumab (Post Month 6)
Total, other (not including serious) adverse events                       
# participants affected / at risk   51/204 (25.00%)   44/201 (21.89%)   18/108 (16.67%)   50/204 (24.51%)   18/232 (7.76%)   8/222 (3.60%)   3/59 (5.08%)   18/204 (8.82%)   36/260 (13.85%)   44/253 (17.39%)   24/204 (11.76%) 
Gastrointestinal disorders                       
Abdominal pain upper * 1                       
# participants affected / at risk   4/204 (1.96%)   2/201 (1.00%)   1/108 (0.93%)   3/204 (1.47%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   1/260 (0.38%)   7/253 (2.77%)   0/204 (0.00%) 
Diarrhoea * 1                       
# participants affected / at risk   5/204 (2.45%)   2/201 (1.00%)   0/108 (0.00%)   2/204 (0.98%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Dyspepsia * 1                       
# participants affected / at risk   4/204 (1.96%)   3/201 (1.49%)   2/108 (1.85%)   3/204 (1.47%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Vomiting * 1                       
# participants affected / at risk   4/204 (1.96%)   0/201 (0.00%)   1/108 (0.93%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
General disorders                       
Oedema peripheral * 1                       
# participants affected / at risk   3/204 (1.47%)   4/201 (1.99%)   3/108 (2.78%)   3/204 (1.47%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Infections and infestations                       
Bronchitis * 1                       
# participants affected / at risk   2/204 (0.98%)   3/201 (1.49%)   1/108 (0.93%)   4/204 (1.96%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   7/260 (2.69%)   10/253 (3.95%)   4/204 (1.96%) 
Herpes zoster * 1                       
# participants affected / at risk   0/204 (0.00%)   5/201 (2.49%)   0/108 (0.00%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   3/260 (1.15%)   6/253 (2.37%)   4/204 (1.96%) 
Nasopharyngitis * 1                       
# participants affected / at risk   8/204 (3.92%)   4/201 (1.99%)   0/108 (0.00%)   7/204 (3.43%)   5/232 (2.16%)   2/222 (0.90%)   1/59 (1.69%)   3/204 (1.47%)   8/260 (3.08%)   3/253 (1.19%)   5/204 (2.45%) 
Upper respiratory tract infection * 1                       
# participants affected / at risk   9/204 (4.41%)   7/201 (3.48%)   1/108 (0.93%)   7/204 (3.43%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   9/260 (3.46%)   6/253 (2.37%)   4/204 (1.96%) 
Urinary tract infection * 1                       
# participants affected / at risk   5/204 (2.45%)   2/201 (1.00%)   0/108 (0.00%)   7/204 (3.43%)   5/232 (2.16%)   1/222 (0.45%)   0/59 (0.00%)   6/204 (2.94%)   2/260 (0.77%)   4/253 (1.58%)   5/204 (2.45%) 
Pharyngitis * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   1/232 (0.43%)   1/222 (0.45%)   0/59 (0.00%)   4/204 (1.96%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Injury, poisoning and procedural complications                       
Fall * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   4/232 (1.72%)   2/222 (0.90%)   2/59 (3.39%)   1/204 (0.49%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Investigations                       
Alanine aminotransferase increased * 1                       
# participants affected / at risk   3/204 (1.47%)   4/201 (1.99%)   0/108 (0.00%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   3/260 (1.15%)   5/253 (1.98%)   1/204 (0.49%) 
Blood creatine phosphokinase increased * 1                       
# participants affected / at risk   1/204 (0.49%)   4/201 (1.99%)   1/108 (0.93%)   1/204 (0.49%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Arthralgia * 1                       
# participants affected / at risk   2/204 (0.98%)   1/201 (0.50%)   1/108 (0.93%)   4/204 (1.96%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   7/253 (2.77%)   1/204 (0.49%) 
Rheumatoid arthritis * 1                       
# participants affected / at risk   4/204 (1.96%)   0/201 (0.00%)   2/108 (1.85%)   1/204 (0.49%)   3/232 (1.29%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Back pain * 1                       
# participants affected / at risk   0/204 (0.00%)   0/201 (0.00%)   0/108 (0.00%)   0/204 (0.00%)   3/232 (1.29%)   2/222 (0.90%)   0/59 (0.00%)   5/204 (2.45%)   2/260 (0.77%)   3/253 (1.19%)   1/204 (0.49%) 
Nervous system disorders                       
Headache * 1                       
# participants affected / at risk   8/204 (3.92%)   6/201 (2.99%)   2/108 (1.85%)   5/204 (2.45%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Cough * 1                       
# participants affected / at risk   0/204 (0.00%)   2/201 (1.00%)   3/108 (2.78%)   4/204 (1.96%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Skin and subcutaneous tissue disorders                       
Rash * 1                       
# participants affected / at risk   1/204 (0.49%)   3/201 (1.49%)   1/108 (0.93%)   4/204 (1.96%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   0/260 (0.00%)   0/253 (0.00%)   0/204 (0.00%) 
Vascular disorders                       
Hypertension * 1                       
# participants affected / at risk   2/204 (0.98%)   5/201 (2.49%)   2/108 (1.85%)   0/204 (0.00%)   0/232 (0.00%)   0/222 (0.00%)   0/59 (0.00%)   0/204 (0.00%)   7/260 (2.69%)   3/253 (1.19%)   2/204 (0.98%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRAv13.1



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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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