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Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851318
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : September 17, 2014
Last Update Posted : November 2, 2014
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Certolizumab pegol
Drug: Methotrexate
Enrollment 285
Recruitment Details Patients with rheumatoid arthritis (RA) who participated in Study 275-08-001 (NCT00791999) were eligible for this study.
Pre-assignment Details Participants were assigned to treatment groups based on whether they discontinued study 275-08-001 at Week 16 or completed Week 24 and based on American College of Rheumatology 20% (ACR20) response at Week 24.
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Period Title: Overall Study
Started 81 19 93 92
Completed Week 24 69 17 90 87
Completed Week 52 64 16 87 85
Completed 51 14 72 73
Not Completed 30 5 21 19
Reason Not Completed
Withdrawal by Subject             7             1             5             3
Adverse Event             13             2             9             12
Pregnancy             0             0             1             1
Lack of Efficacy             8             2             4             2
Non-compliance with Study Procedures             2             0             1             0
Physician Decision             0             0             1             1
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg Total
Hide Arm/Group Description Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Total of all reporting groups
Overall Number of Baseline Participants 81 19 93 92 285
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 19 participants 93 participants 92 participants 285 participants
51.8  (10.7) 51.3  (13.7) 52.9  (11.0) 54.1  (11.0) 52.8  (11.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 81 participants 19 participants 93 participants 92 participants 285 participants
< 65 years 72 16 81 76 245
≧ 65 years 9 3 12 16 40
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 19 participants 93 participants 92 participants 285 participants
Female
67
  82.7%
16
  84.2%
76
  81.7%
77
  83.7%
236
  82.8%
Male
14
  17.3%
3
  15.8%
17
  18.3%
15
  16.3%
49
  17.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 81 participants 19 participants 93 participants 92 participants 285 participants
81 19 93 92 285
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 81 participants 19 participants 93 participants 92 participants 285 participants
56.30  (12.00) 54.27  (9.57) 55.81  (11.34) 54.92  (9.47) 55.56  (10.83)
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:

Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.

A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.

Time Frame From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one study drug administration were included in the safety analysis population (SAF).
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description:
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Overall Number of Participants Analyzed 81 19 93 92
Measure Type: Number
Unit of Measure: participants
Any adverse event 77 18 92 90
Mild adverse events 20 4 36 33
Moderate adverse events 47 12 47 45
Severe adverse events 10 2 9 12
Serious adverse events (SAE) 21 4 20 23
Serious adverse events leading to death 1 0 0 0
Non-fatal serious adverse events 21 4 20 23
Adverse events leading to withdrawal 13 2 9 12
Infections induced by pathogen in study drug 0 0 0 0
Overdoses 0 0 0 0
Adverse events occurring within 2 hours of dosing 1 0 0 0
2.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Hide Description

A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:

  • ≥ 20% improvement in 68 tender joint count;
  • ≥ 20% improvement in 66 swollen joint count; and
  • ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
    • C-Reactive Protein (CRP).
Time Frame Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description:
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Overall Number of Participants Analyzed 81 19 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24
71.6
(60.5 to 81.1)
68.4
(43.4 to 87.4)
96.8
(90.9 to 99.3)
98.9
(94.1 to 100.0)
Week 52
76.5
(65.8 to 85.2)
84.2
(60.4 to 96.6)
98.9
(94.2 to 100.0)
94.6
(87.8 to 98.2)
Final Assessment
80.2
(69.9 to 88.3)
89.5
(66.9 to 98.7)
95.7
(89.4 to 98.8)
94.6
(87.8 to 98.2)
3.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Hide Description

A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:

  • ≥ 50% improvement in 68 tender joint count;
  • ≥ 50% improvement in 66 swollen joint count; and
  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
    • C-Reactive Protein (CRP).
Time Frame Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description:
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Overall Number of Participants Analyzed 81 19 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24
42.0
(31.1 to 53.5)
36.8
(16.3 to 61.6)
83.9
(74.8 to 90.7)
82.6
(73.3 to 89.7)
Week 52
48.1
(36.9 to 59.5)
57.9
(33.5 to 79.7)
87.1
(78.5 to 93.2)
88.0
(79.6 to 93.9)
Final Assessment
60.5
(49.0 to 71.2)
57.9
(33.5 to 79.7)
86.0
(77.3 to 92.3)
85.9
(77.0 to 92.3)
4.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Hide Description

A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:

  • ≥ 70% improvement in 68 tender joint count;
  • ≥ 70% improvement in 66 swollen joint count; and
  • ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a 100 mm VAS);
    • Physician's global assessment of disease activity (measured on a 100 mm VAS);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
    • C-Reactive Protein (CRP).
Time Frame Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description:
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Overall Number of Participants Analyzed 81 19 93 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24
14.8
(7.9 to 24.4)
26.3
(9.1 to 51.2)
60.2
(49.5 to 70.2)
47.8
(37.3 to 58.5)
Week 52
30.9
(21.1 to 42.1)
31.6
(12.6 to 56.6)
64.5
(53.9 to 74.2)
57.6
(46.9 to 67.9)
Final Assessment
44.4
(33.4 to 55.9)
31.6
(12.6 to 56.6)
65.6
(55.0 to 75.1)
62.0
(51.2 to 71.9)
5.Secondary Outcome
Title Change From Baseline in Disease Activity Score (DAS) 28
Hide Description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables:

  • 28 tender joint count;
  • 28 swollen joint count;
  • Erythrocyte sedimentation rate (ESR);
  • Patient's global assessment of disease activity.

To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.

The data before study drug administration of 275-08-001 Study was utilized for Baseline.

DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Time Frame Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description:
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Overall Number of Participants Analyzed 81 19 93 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 -2.28  (1.27) -2.32  (1.25) -3.24  (1.11) -3.23  (1.24)
Week 52 -2.65  (1.44) -2.34  (0.96) -3.51  (1.15) -3.21  (1.29)
Final Assessment -2.98  (1.82) -2.67  (1.44) -3.49  (1.27) -3.46  (1.31)
6.Secondary Outcome
Title Change From Baseline in Modified Total Sharp Score (mTSS)
Hide Description

X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.

The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.

The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).

Time Frame Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available mTSS data. Linear extrapolation method was used.
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description:
Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Overall Number of Participants Analyzed 64 16 86 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from Baseline to Week 0 1.48  (2.70) 1.69  (2.29) 0.71  (2.75) 0.08  (1.83)
Change from Baseline to Week 100 (N=61, 16, 83, 83 5.13  (11.76) 4.97  (8.79) 3.77  (12.43) 2.12  (9.55)
Time Frame From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
Adverse Event Reporting Description All participants who received at least one study drug administration were included in the safety analysis population (SAF).
 
Arm/Group Title Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Hide Arm/Group Description Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan. Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
All-Cause Mortality
Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/81 (25.93%)   4/19 (21.05%)   20/93 (21.51%)   23/92 (25.00%) 
Cardiac disorders         
Angina pectoris   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Atrial fibrillation   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Myocardial ischaemia   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Sick sinus syndrome   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Ear and labyrinth disorders         
Sudden hearing loss   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Eye disorders         
Cataract   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Gastrointestinal disorders         
Enterocolitis   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Haemorrhoids   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Ileus paralytic   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
General disorders         
Chest Pain   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Hepatobiliary disorders         
Hepatic function abnormal   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Hepatic steatosis   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Infections and infestations         
Appendicitis   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Bronchitis   1/81 (1.23%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Bronchopneumonia   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Cellulitis   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Gastroenteritis   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Herpes zoster   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Influenza   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Otitis media chronic   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Pneumonia   1/81 (1.23%)  0/19 (0.00%)  2/93 (2.15%)  0/92 (0.00%) 
Pyelonephritis   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Pyomyositis   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Sinusitis   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Subcutaneous abscess   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Urinary tract infection   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Abscess limb   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Infective tenosynovitis   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Pneumonia bacterial   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Atypical mycobacterial infection   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Pneumocystis jiroveci pneumonia   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  2/92 (2.17%) 
Femoral neck fracture   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Femur fracture   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Spinal compression fracture   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Tendon rupture   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  1/92 (1.09%) 
Contusion   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Pelvic fracture   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Investigations         
Computerised tomogram thorax abnormal   1/81 (1.23%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Arthritis   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  3/92 (3.26%) 
Joint destruction   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Lumbar spinal stenosis   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Osteonecrosis   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Rheumatoid arthritis   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  4/92 (4.35%) 
Synovial cyst   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Neck mass   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Foot deformity   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
B-cell lymphoma   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Breast cancer   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Colon cancer   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Gastric cancer   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Malignant melanoma   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Meningioma   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Nasal sinus cancer   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Ovarian cancer   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Uterine leiomyoma   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  1/92 (1.09%) 
Ovarian adenoma   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Thyroid cancer   0/81 (0.00%)  0/19 (0.00%)  2/93 (2.15%)  0/92 (0.00%) 
Nervous system disorders         
Cerebral haemorrhage   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Convulsion   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Dementia   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Facial palsy   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Intracranial aneurysm   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Subarachnoid haemorrhage   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  2/92 (2.17%) 
Reproductive system and breast disorders         
Endometrial hyperplasia   1/81 (1.23%)  0/19 (0.00%)  0/93 (0.00%)  0/92 (0.00%) 
Haemorrhagic ovarian cyst   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders         
Interstitial lung disease   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Laryngeal mass   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Organising pneumonia   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperkeratosis   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Surgical and medical procedures         
Abortion induced   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Removal of internal fixation   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Toe operation   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Vascular disorders         
Deep vein thrombosis   0/81 (0.00%)  0/19 (0.00%)  0/93 (0.00%)  1/92 (1.09%) 
Extremity necrosis   0/81 (0.00%)  0/19 (0.00%)  1/93 (1.08%)  0/92 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Discontinued Non-responders 200 mg Completed Non-responders 200 mg Completed Responders 200 mg Completed Responders 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   77/81 (95.06%)   18/19 (94.74%)   91/93 (97.85%)   90/92 (97.83%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia   3/81 (3.70%)  1/19 (5.26%)  8/93 (8.60%)  5/92 (5.43%) 
Ear and labyrinth disorders         
Vertigo   2/81 (2.47%)  2/19 (10.53%)  2/93 (2.15%)  2/92 (2.17%) 
Endocrine disorders         
Anovulatory cycle   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Eye disorders         
Cataract   3/81 (3.70%)  0/19 (0.00%)  5/93 (5.38%)  3/92 (3.26%) 
Conjunctivitis allergic   8/81 (9.88%)  0/19 (0.00%)  8/93 (8.60%)  8/92 (8.70%) 
Diabetic retinopathy   2/81 (2.47%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Dry eye   2/81 (2.47%)  2/19 (10.53%)  4/93 (4.30%)  2/92 (2.17%) 
Eyelid oedema   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Gastrointestinal disorders         
Abdominal pain lower   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Abdominal pain upper   5/81 (6.17%)  1/19 (5.26%)  0/93 (0.00%)  3/92 (3.26%) 
Constipation   10/81 (12.35%)  2/19 (10.53%)  2/93 (2.15%)  9/92 (9.78%) 
Dental caries   8/81 (9.88%)  1/19 (5.26%)  9/93 (9.68%)  6/92 (6.52%) 
Diarrhoea   5/81 (6.17%)  2/19 (10.53%)  6/93 (6.45%)  9/92 (9.78%) 
Dry mouth   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  1/92 (1.09%) 
Duodenal polyp   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Enterocolitis   1/81 (1.23%)  0/19 (0.00%)  6/93 (6.45%)  2/92 (2.17%) 
Gastric ulcer   2/81 (2.47%)  1/19 (5.26%)  0/93 (0.00%)  2/92 (2.17%) 
Gastritis   5/81 (6.17%)  2/19 (10.53%)  3/93 (3.23%)  7/92 (7.61%) 
Gingivitis   0/81 (0.00%)  2/19 (10.53%)  2/93 (2.15%)  2/92 (2.17%) 
Nausea   2/81 (2.47%)  1/19 (5.26%)  4/93 (4.30%)  3/92 (3.26%) 
Periodontitis   5/81 (6.17%)  2/19 (10.53%)  8/93 (8.60%)  4/92 (4.35%) 
Reflux oesophagitis   2/81 (2.47%)  1/19 (5.26%)  3/93 (3.23%)  6/92 (6.52%) 
Stomach discomfort   2/81 (2.47%)  0/19 (0.00%)  6/93 (6.45%)  6/92 (6.52%) 
Stomatitis   7/81 (8.64%)  1/19 (5.26%)  3/93 (3.23%)  8/92 (8.70%) 
Vomiting   0/81 (0.00%)  3/19 (15.79%)  3/93 (3.23%)  6/92 (6.52%) 
Gastrointestinal hypomotility   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Hypoaesthesia oral   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
General disorders         
Asthenia   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Chest pain   3/81 (3.70%)  1/19 (5.26%)  2/93 (2.15%)  2/92 (2.17%) 
Cyst   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  0/92 (0.00%) 
Injection site reaction   6/81 (7.41%)  0/19 (0.00%)  1/93 (1.08%)  1/92 (1.09%) 
Pyrexia   4/81 (4.94%)  1/19 (5.26%)  2/93 (2.15%)  1/92 (1.09%) 
Hepatobiliary disorders         
Hepatic function abnormal   6/81 (7.41%)  1/19 (5.26%)  10/93 (10.75%)  7/92 (7.61%) 
Hepatic steatosis   6/81 (7.41%)  0/19 (0.00%)  5/93 (5.38%)  4/92 (4.35%) 
Immune system disorders         
Seasonal allergy   5/81 (6.17%)  1/19 (5.26%)  10/93 (10.75%)  6/92 (6.52%) 
Contrast media allergy   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Infections and infestations         
Bronchitis   10/81 (12.35%)  4/19 (21.05%)  14/93 (15.05%)  8/92 (8.70%) 
Cellulitis   0/81 (0.00%)  1/19 (5.26%)  2/93 (2.15%)  3/92 (3.26%) 
Cystitis   7/81 (8.64%)  2/19 (10.53%)  6/93 (6.45%)  4/92 (4.35%) 
Gastroenteritis   4/81 (4.94%)  1/19 (5.26%)  9/93 (9.68%)  6/92 (6.52%) 
Herpes simplex   1/81 (1.23%)  1/19 (5.26%)  1/93 (1.08%)  3/92 (3.26%) 
Herpes zoster   2/81 (2.47%)  2/19 (10.53%)  3/93 (3.23%)  4/92 (4.35%) 
Influenza   7/81 (8.64%)  1/19 (5.26%)  9/93 (9.68%)  7/92 (7.61%) 
Localised infection   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  0/92 (0.00%) 
Nasal vestibulitis   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  1/92 (1.09%) 
Nasopharyngitis   41/81 (50.62%)  12/19 (63.16%)  53/93 (56.99%)  45/92 (48.91%) 
Onychomycosis   0/81 (0.00%)  2/19 (10.53%)  3/93 (3.23%)  3/92 (3.26%) 
Pharyngitis   15/81 (18.52%)  1/19 (5.26%)  18/93 (19.35%)  10/92 (10.87%) 
Pneumonia   1/81 (1.23%)  1/19 (5.26%)  1/93 (1.08%)  3/92 (3.26%) 
Sialoadenitis   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Sinusitis   4/81 (4.94%)  1/19 (5.26%)  2/93 (2.15%)  5/92 (5.43%) 
Tinea pedis   5/81 (6.17%)  0/19 (0.00%)  4/93 (4.30%)  9/92 (9.78%) 
Upper respiratory tract infection   15/81 (18.52%)  3/19 (15.79%)  20/93 (21.51%)  20/92 (21.74%) 
Urinary tract infection   3/81 (3.70%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Tinea infection   0/81 (0.00%)  0/19 (0.00%)  5/93 (5.38%)  2/92 (2.17%) 
Oral herpes   6/81 (7.41%)  0/19 (0.00%)  7/93 (7.53%)  6/92 (6.52%) 
Injury, poisoning and procedural complications         
Arthropod sting   4/81 (4.94%)  1/19 (5.26%)  3/93 (3.23%)  2/92 (2.17%) 
Chillblains   1/81 (1.23%)  2/19 (10.53%)  3/93 (3.23%)  1/92 (1.09%) 
Tendon rupture   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  2/92 (2.17%) 
Excoriation   0/81 (0.00%)  0/19 (0.00%)  5/93 (5.38%)  2/92 (2.17%) 
Contusion   9/81 (11.11%)  1/19 (5.26%)  12/93 (12.90%)  6/92 (6.52%) 
Thermal burn   0/81 (0.00%)  1/19 (5.26%)  2/93 (2.15%)  2/92 (2.17%) 
Device failure   1/81 (1.23%)  2/19 (10.53%)  1/93 (1.08%)  1/92 (1.09%) 
Tooth fracture   1/81 (1.23%)  1/19 (5.26%)  1/93 (1.08%)  1/92 (1.09%) 
Bone fissure   1/81 (1.23%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Investigations         
Alanine aminotransferase increased   1/81 (1.23%)  1/19 (5.26%)  1/93 (1.08%)  1/92 (1.09%) 
Aspartate aminotransferase increased   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  1/92 (1.09%) 
Blood pressure increased   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  0/92 (0.00%) 
Metabolism and nutrition disorders         
Anorexia   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Diabetes mellitus   2/81 (2.47%)  2/19 (10.53%)  1/93 (1.08%)  0/92 (0.00%) 
Hypercholesterolaemia   6/81 (7.41%)  0/19 (0.00%)  6/93 (6.45%)  4/92 (4.35%) 
Hyponatraemia   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia   0/81 (0.00%)  1/19 (5.26%)  4/93 (4.30%)  5/92 (5.43%) 
Back pain   5/81 (6.17%)  3/19 (15.79%)  7/93 (7.53%)  8/92 (8.70%) 
Bursitis   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  1/92 (1.09%) 
Rheumatoid arthritis   6/81 (7.41%)  4/19 (21.05%)  10/93 (10.75%)  13/92 (14.13%) 
Sjogren's syndrome   2/81 (2.47%)  1/19 (5.26%)  1/93 (1.08%)  1/92 (1.09%) 
Spinal osteoarthritis   2/81 (2.47%)  1/19 (5.26%)  6/93 (6.45%)  3/92 (3.26%) 
Synovitis   1/81 (1.23%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Haemangioma of skin   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Skin papilloma   2/81 (2.47%)  1/19 (5.26%)  1/93 (1.08%)  0/92 (0.00%) 
Nervous system disorders         
Headache   0/81 (0.00%)  3/19 (15.79%)  2/93 (2.15%)  5/92 (5.43%) 
Sciatica   0/81 (0.00%)  1/19 (5.26%)  2/93 (2.15%)  1/92 (1.09%) 
Psychiatric disorders         
Insomnia   1/81 (1.23%)  0/19 (0.00%)  1/93 (1.08%)  5/92 (5.43%) 
Psychosomatic disease   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Renal and urinary disorders         
Neurogenic bladder   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Tubulointerstitial nephritis   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough   3/81 (3.70%)  1/19 (5.26%)  3/93 (3.23%)  6/92 (6.52%) 
Rhinitis allergic   4/81 (4.94%)  0/19 (0.00%)  8/93 (8.60%)  7/92 (7.61%) 
Upper respiratory tract inflammation   3/81 (3.70%)  0/19 (0.00%)  4/93 (4.30%)  5/92 (5.43%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact   7/81 (8.64%)  0/19 (0.00%)  6/93 (6.45%)  6/92 (6.52%) 
Eczema   9/81 (11.11%)  2/19 (10.53%)  14/93 (15.05%)  12/92 (13.04%) 
Eczema asteatotic   1/81 (1.23%)  4/19 (21.05%)  4/93 (4.30%)  2/92 (2.17%) 
Haemorrhage subcutaneous   1/81 (1.23%)  1/19 (5.26%)  0/93 (0.00%)  2/92 (2.17%) 
Hyperkeratosis   7/81 (8.64%)  1/19 (5.26%)  7/93 (7.53%)  3/92 (3.26%) 
Nail disorder   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Photosensitivity reaction   2/81 (2.47%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Pruritus   3/81 (3.70%)  1/19 (5.26%)  0/93 (0.00%)  3/92 (3.26%) 
Rash   5/81 (6.17%)  3/19 (15.79%)  7/93 (7.53%)  8/92 (8.70%) 
Asteatosis   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  3/92 (3.26%) 
Vascular disorders         
Hypertension   5/81 (6.17%)  2/19 (10.53%)  9/93 (9.68%)  11/92 (11.96%) 
Peripheral vascular disorder   0/81 (0.00%)  1/19 (5.26%)  1/93 (1.08%)  0/92 (0.00%) 
Deep vein thrombosis   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Hot flush   0/81 (0.00%)  1/19 (5.26%)  0/93 (0.00%)  0/92 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director, Global Medical Sciences
Organization: Astellas Pharma Inc.
EMail: ClinicalTrials.Disclosure@astellas.com
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00851318    
Other Study ID Numbers: CDP870-275-08-002
JapicCTI-090700
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: September 9, 2014
Results First Posted: September 17, 2014
Last Update Posted: November 2, 2014