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Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

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: NCT00503139
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Drug: Enbrel (etanercept)
Enrollment 684
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Period Title: Overall Study
Started 684
Completed 676
Not Completed 8
Reason Not Completed
Case Report Forms were not collected             4
Protocol Violation             4
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Baseline Participants 676
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 676 participants
<65 years 454
>=65 years 222
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 676 participants
Female
559
  82.7%
Male
117
  17.3%
1.Primary Outcome
Title Number of Participants in Safety Analysis Population of Etanercept
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 676
Measure Type: Number
Unit of Measure: Participants
Within 6 months 676
6 to 12 months 561
Within 1 year 676
1 to 2 years 475
2 to 3 years 372
3 years or more 176
2.Primary Outcome
Title Number of Participants With Treatment Related Adverse Events of Etanercept
Hide Description Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 676
Measure Type: Number
Unit of Measure: Participants
Within 6 months (N=676) 117
6 to 12 months (N=561) 84
Within 1 year (N=676) 184
1 to 2 years (N=475) 90
2 to 3 years (N=372) 43
3 years or more (N=176) 1
3.Primary Outcome
Title Number of Participants With Serious Treatment Related Adverse Events of Etanercept
Hide Description Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 676
Measure Type: Number
Unit of Measure: Participants
Within 6 months (N = 676) 12
6 to 12 months (N = 561) 17
Within 1 year (N = 676) 29
1 to 2 years (N = 475) 24
2 to 3 years (N = 372) 13
3 years or more (N = 176) 0
4.Primary Outcome
Title Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept
Hide Description Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population (N = number of participants evaluated) consisted of the participants who received etanercept for rheumatoid arthritis because of an inadequate response to the conventional therapies and had no history of or concurrent malignant tumors.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 676
Measure Type: Number
Unit of Measure: Participants
16
5.Primary Outcome
Title European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
Hide Description DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (4/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 583
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
At 6 months (N = 533)
84.05
(80.66 to 87.06)
At 1 year (N = 566)
82.51
(79.12 to 85.55)
At 1.5 years (N = 576)
79.69
(76.17 to 82.90)
At 2 years (N = 577)
81.98
(78.59 to 85.03)
6.Secondary Outcome
Title Modified Health Assessment Questionnaire (mHAQ) Score
Hide Description Modified Health Assessment Questionnaire-(mHAQ): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom mHAQ was calculated. The last observation carried forward (LOCF) method was used to impute missing data.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 583
Mean (Standard Deviation)
Unit of Measure: Score
At Baseline (N = 583) 0.82  (0.64)
At 6 months (N = 490) 0.45  (0.58)
At 1 year (N = 520) 0.46  (0.61)
At 1.5 years (N = 526) 0.45  (0.61)
At 2 years (N = 531) 0.46  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (Genetical Recombination)
Comments The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sample
Comments A two-sided t-test was performed to test the hypothesis.
7.Secondary Outcome
Title Visual Analog Fatigue Scale (VAFS)
Hide Description Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom VAS Fatigue was calculated. The last observation carried forward (LOCF) method was used to impute missing data.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 583
Mean (Standard Deviation)
Unit of Measure: Score
At Baseline (N = 583) 49.1  (27.1)
At 6 months (N = 477) 26.1  (22.6)
At 1 year (N = 509) 25.2  (22.8)
At 1.5 years (N = 513) 25.3  (23.2)
At 2 years (N = 518) 26.0  (23.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept (Genetical Recombination)
Comments The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sample
Comments A two-sided t-test was performed to test the hypothesis.
8.Secondary Outcome
Title European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
Hide Description DAS28-3 (ESR) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count and ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population (N = number of participants evaluated) consisted of the participants in whom DAS28 (3/ESR) was calculated. The last observation carried forward (LOCF) method was used to impute missing data.
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description:
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
Overall Number of Participants Analyzed 583
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
At 6 months (N = 533)
81.80
(78.26 to 84.99)
1 year (N = 566)
81.10
(77.62 to 84.24)
1.5 years (N = 576)
79.69
(76.17 to 82.90)
2 years (N = 577)
80.42
(76.94 to 83.58)
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of treatment related adverse events during the study
 
Arm/Group Title Etanercept (Genetical Recombination)
Hide Arm/Group Description Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
All-Cause Mortality
Etanercept (Genetical Recombination)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept (Genetical Recombination)
Affected / at Risk (%) # Events
Total   77/676 (11.39%)    
Blood and lymphatic system disorders   
Lymphadenopathy  1  1/676 (0.15%)  1
Pancytopenia  1  1/676 (0.15%)  1
Cardiac disorders   
Cardiac failure  1  1/676 (0.15%)  1
Gastrointestinal disorders   
Gastrointestinal necrosis  1  1/676 (0.15%)  1
Small intestinal haemorrhage  1  1/676 (0.15%)  1
Volvulus of small bowel  1  1/676 (0.15%)  1
General disorders   
Pyrexia  1  1/676 (0.15%)  1
Sudden death  1  1/676 (0.15%)  1
Sudden cardiac death  1  1/676 (0.15%)  1
Hepatobiliary disorders   
Hepatic function abnormal  1  1/676 (0.15%)  1
Immune system disorders   
Anaphylactic shock  1  1/676 (0.15%)  1
Infections and infestations   
Bacteraemia  1  1/676 (0.15%)  1
Bronchitis  1  3/676 (0.44%)  3
Bronchopulmonary aspergillosis  1  2/676 (0.30%)  2
Cellulitis  1  1/676 (0.15%)  1
Disseminated tuberculosis  1  1/676 (0.15%)  1
Diverticulitis  1  1/676 (0.15%)  1
Gastroenteritis  1  1/676 (0.15%)  1
Herpes zoster  1  3/676 (0.44%)  3
Pharyngitis  1  1/676 (0.15%)  1
Pneumonia  1  8/676 (1.18%)  8
Pulmonary tuberculosis  1  1/676 (0.15%)  1
Pyelonephritis acute  1  1/676 (0.15%)  1
Sepsis  1  1/676 (0.15%)  1
Sinusitis  1  1/676 (0.15%)  1
Urinary tract infection  1  2/676 (0.30%)  3
Viral infection  1  2/676 (0.30%)  2
Skin bacterial infection  1  1/676 (0.15%)  1
Arthritis bacterial  1  1/676 (0.15%)  1
Bone tuberculosis  1  1/676 (0.15%)  1
Abdominal abscess  1  1/676 (0.15%)  1
Pneumonia bacterial  1  2/676 (0.30%)  2
Atypical mycobacterial infection  1  1/676 (0.15%)  1
Pneumocystis jiroveci pneumonia  1  1/676 (0.15%)  1
Device related infection  1  1/676 (0.15%)  1
Injury, poisoning and procedural complications   
Femoral neck fracture  1  1/676 (0.15%)  1
Humerus fracture  1  1/676 (0.15%)  1
Spinal compression fracture  1  1/676 (0.15%)  1
Spinal cord injury cervical  1  1/676 (0.15%)  1
Tendon rupture  1  1/676 (0.15%)  1
Investigations   
Granulocyte count decreased  1  1/676 (0.15%)  1
Lymphocyte count decreased  1  1/676 (0.15%)  1
Metabolism and nutrition disorders   
Metabolic acidosis  1  1/676 (0.15%)  1
Musculoskeletal and connective tissue disorders   
Spinal column stenosis  1  1/676 (0.15%)  1
Systemic lupus erythematosus  1  1/676 (0.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bowen's disease  1  1/676 (0.15%)  1
Breast cancer  1  3/676 (0.44%)  3
Colon cancer  1  1/676 (0.15%)  1
Gastric cancer  1  3/676 (0.44%)  3
Malignant pleural effusion  1  1/676 (0.15%)  1
Ovarian cancer  1  1/676 (0.15%)  1
Sarcoma uterus  1  1/676 (0.15%)  1
Histiocytosis haematophagic  1  1/676 (0.15%)  1
Lung neoplasm malignant  1  2/676 (0.30%)  2
Large intestine carcinoma  1  1/676 (0.15%)  1
Thyroid cancer  1  2/676 (0.30%)  2
Nervous system disorders   
Carpal tunnel syndrome  1  1/676 (0.15%)  1
Cerebral haemorrhage  1  1/676 (0.15%)  1
Cerebral infarction  1  1/676 (0.15%)  1
Dyskinesia  1  1/676 (0.15%)  1
Leukoencephalopathy  1  1/676 (0.15%)  1
Senile dementia  1  1/676 (0.15%)  1
Vertebral artery occlusion  1  1/676 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  6/676 (0.89%)  6
Pleurisy  1  1/676 (0.15%)  1
Pneumothorax  1  1/676 (0.15%)  1
Pulmonary alveolar haemorrhage  1  1/676 (0.15%)  1
Upper respiratory tract inflammation  1  1/676 (0.15%)  1
Organising pneumonia  1  1/676 (0.15%)  1
Surgical and medical procedures   
Renal stone removal  1  1/676 (0.15%)  1
Joint arthroplasty  1  1/676 (0.15%)  1
Vascular disorders   
Venous thrombosis  1  1/676 (0.15%)  1
Aortic dissection rupture  1  1/676 (0.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept (Genetical Recombination)
Affected / at Risk (%) # Events
Total   261/676 (38.61%)    
Blood and lymphatic system disorders   
Anaemia  1  6/676 (0.89%)  7
Granulocytopenia  1  1/676 (0.15%)  1
Iron deficiency anaemia  1  2/676 (0.30%)  2
Leukopenia  1  1/676 (0.15%)  1
Lymphadenitis  1  1/676 (0.15%)  1
Thrombocytopenia  1  1/676 (0.15%)  1
Cardiac disorders   
Arrhythmia  1  2/676 (0.30%)  2
Endocrine disorders   
Adrenal insufficiency  1  1/676 (0.15%)  1
Eye disorders   
Cataract  1  2/676 (0.30%)  2
Conjunctivitis allergic  1  1/676 (0.15%)  1
Corneal erosion  1  1/676 (0.15%)  1
Erythema of eyelid  1  1/676 (0.15%)  1
Eyelid oedema  1  1/676 (0.15%)  1
Uveitis  1  1/676 (0.15%)  1
Visual acuity reduced  1  1/676 (0.15%)  1
Eye pruritus  1  1/676 (0.15%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/676 (0.15%)  1
Colonic polyp  1  1/676 (0.15%)  1
Constipation  1  3/676 (0.44%)  3
Diarrhoea  1  8/676 (1.18%)  8
Dry mouth  1  1/676 (0.15%)  1
Enterocolitis  1  3/676 (0.44%)  3
Gastric ulcer  1  4/676 (0.59%)  4
Gastritis  1  2/676 (0.30%)  2
Gastritis erosive  1  1/676 (0.15%)  1
Gastrooesophageal reflux disease  1  3/676 (0.44%)  3
Gingival bleeding  1  1/676 (0.15%)  1
Glossitis  1  1/676 (0.15%)  1
Nausea  1  2/676 (0.30%)  3
Stomatitis  1  7/676 (1.04%)  7
Submaxillary gland enlargement  1  1/676 (0.15%)  1
Vomiting  1  3/676 (0.44%)  3
General disorders   
Feeling abnormal  1  1/676 (0.15%)  1
Generalised oedema  1  1/676 (0.15%)  1
Injection site pain  1  4/676 (0.59%)  4
Injection site reaction  1  30/676 (4.44%)  31
Malaise  1  4/676 (0.59%)  4
Oedema  1  1/676 (0.15%)  1
Oedema peripheral  1  1/676 (0.15%)  1
Pyrexia  1  9/676 (1.33%)  11
Foreign body reaction  1  1/676 (0.15%)  1
Hepatobiliary disorders   
Alcoholic liver disease  1  1/676 (0.15%)  1
Hepatic function abnormal  1  25/676 (3.70%)  30
Hepatic steatosis  1  3/676 (0.44%)  4
Hepatitis  1  1/676 (0.15%)  1
Liver disorder  1  5/676 (0.74%)  5
Infections and infestations   
Acute sinusitis  1  1/676 (0.15%)  1
Acute tonsillitis  1  1/676 (0.15%)  1
Bronchitis  1  19/676 (2.81%)  23
Bronchopneumonia  1  1/676 (0.15%)  1
Cellulitis  1  1/676 (0.15%)  1
Chronic sinusitis  1  1/676 (0.15%)  1
Cystitis  1  4/676 (0.59%)  4
Fungal skin infection  1  1/676 (0.15%)  1
Gastroenteritis  1  4/676 (0.59%)  4
Hepatitis C  1  1/676 (0.15%)  1
Herpes virus infection  1  1/676 (0.15%)  1
Herpes zoster  1  11/676 (1.63%)  11
Influenza  1  2/676 (0.30%)  2
Nail candida  1  1/676 (0.15%)  1
Nasopharyngitis  1  25/676 (3.70%)  27
Onychomycosis  1  2/676 (0.30%)  2
Oral candidiasis  1  1/676 (0.15%)  3
Otitis media  1  2/676 (0.30%)  2
Parotitis  1  1/676 (0.15%)  1
Pharyngitis  1  7/676 (1.04%)  10
Pneumonia  1  6/676 (0.89%)  6
Pyelonephritis  1  2/676 (0.30%)  2
Rash pustular  1  1/676 (0.15%)  1
Sinusitis  1  1/676 (0.15%)  1
Tinea pedis  1  3/676 (0.44%)  3
Tonsillitis  1  1/676 (0.15%)  1
Upper respiratory tract infection  1  1/676 (0.15%)  1
Urinary tract infection  1  2/676 (0.30%)  2
Arthritis bacterial  1  1/676 (0.15%)  1
Enteritis infectious  1  1/676 (0.15%)  1
Genitourinary tract infection  1  1/676 (0.15%)  1
Atypical mycobacterial infection  1  1/676 (0.15%)  1
Respiratory tract infection  1  1/676 (0.15%)  1
Oral herpes  1  3/676 (0.44%)  3
Post procedural infection  1  1/676 (0.15%)  1
Infected dermal cyst  1  1/676 (0.15%)  1
Injury, poisoning and procedural complications   
Ankle fracture  1  1/676 (0.15%)  1
Thoracic vertebral fracture  1  1/676 (0.15%)  1
Muscle strain  1  1/676 (0.15%)  1
Investigations   
Alanine aminotransferase increased  1  2/676 (0.30%)  2
Aspartate aminotransferase increased  1  2/676 (0.30%)  2
Blood lactate dehydrogenase increased  1  3/676 (0.44%)  3
Blood urea increased  1  1/676 (0.15%)  1
Gamma-glutamyltransferase increased  1  4/676 (0.59%)  4
Laboratory test abnormal  1  1/676 (0.15%)  1
Liver function test abnormal  1  7/676 (1.04%)  7
Platelet count decreased  1  3/676 (0.44%)  3
White blood cell count decreased  1  7/676 (1.04%)  7
Blood beta-D-glucan increased  1  4/676 (0.59%)  4
Blood alkaline phosphatase increased  1  1/676 (0.15%)  1
Antinuclear antibody positive  1  1/676 (0.15%)  1
Hepatic enzyme increased  1  6/676 (0.89%)  6
DNA antibody positive  1  1/676 (0.15%)  1
Cell marker increased  1  1/676 (0.15%)  1
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/676 (0.15%)  1
Glucose tolerance impaired  1  1/676 (0.15%)  1
Hyperkalaemia  1  1/676 (0.15%)  1
Hyperuricaemia  1  1/676 (0.15%)  1
Lipid metabolism disorder  1  1/676 (0.15%)  1
Hyperlipidaemia  1  3/676 (0.44%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/676 (0.30%)  2
Arthritis  1  1/676 (0.15%)  1
Flank pain  1  1/676 (0.15%)  1
Lumbar spinal stenosis  1  2/676 (0.30%)  2
Osteoporosis  1  2/676 (0.30%)  2
Pain in extremity  1  1/676 (0.15%)  1
Periarthritis  1  1/676 (0.15%)  1
Sjogren's syndrome  1  1/676 (0.15%)  1
Spinal osteoarthritis  1  1/676 (0.15%)  1
Intervertebral disc protrusion  1  1/676 (0.15%)  1
Foot deformity  1  1/676 (0.15%)  1
Intervertebral disc disorder  1  1/676 (0.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Histiocytosis haematophagic  1  1/676 (0.15%)  1
Nervous system disorders   
Convulsion  1  1/676 (0.15%)  2
Dizziness  1  5/676 (0.74%)  5
Headache  1  5/676 (0.74%)  5
Sciatica  1  1/676 (0.15%)  1
Psychiatric disorders   
Insomnia  1  4/676 (0.59%)  5
Renal and urinary disorders   
Nephrolithiasis  1  1/676 (0.15%)  1
Neurogenic bladder  1  1/676 (0.15%)  1
Pollakiuria  1  1/676 (0.15%)  1
Renal failure  1  1/676 (0.15%)  1
Urge incontinence  1  1/676 (0.15%)  1
Diabetic nephropathy  1  1/676 (0.15%)  1
Renal impairment  1  1/676 (0.15%)  1
Stress urinary incontinence  1  1/676 (0.15%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/676 (0.15%)  1
Menorrhagia  1  1/676 (0.15%)  1
Genital haemorrhage  1  1/676 (0.15%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/676 (0.15%)  1
Bronchitis chronic  1  1/676 (0.15%)  1
Cough  1  5/676 (0.74%)  5
Interstitial lung disease  1  4/676 (0.59%)  4
Productive cough  1  1/676 (0.15%)  1
Rhinitis allergic  1  2/676 (0.30%)  2
Rhinorrhoea  1  1/676 (0.15%)  1
Sneezing  1  1/676 (0.15%)  1
Upper respiratory tract inflammation  1  19/676 (2.81%)  24
Oropharyngeal discomfort  1  1/676 (0.15%)  1
Oropharyngeal pain  1  2/676 (0.30%)  2
Skin and subcutaneous tissue disorders   
Dermatomyositis  1  1/676 (0.15%)  1
Drug eruption  1  2/676 (0.30%)  2
Eczema  1  9/676 (1.33%)  11
Erythema  1  8/676 (1.18%)  10
Heat rash  1  1/676 (0.15%)  1
Hyperkeratosis  1  2/676 (0.30%)  2
Prurigo  1  1/676 (0.15%)  1
Pruritus  1  11/676 (1.63%)  12
Pustular psoriasis  1  1/676 (0.15%)  1
Rash  1  13/676 (1.92%)  15
Rash generalised  1  1/676 (0.15%)  1
Skin chapped  1  1/676 (0.15%)  1
Urticaria  1  4/676 (0.59%)  7
Pruritus generalised  1  2/676 (0.30%)  2
Butterfly rash  1  1/676 (0.15%)  1
Surgical and medical procedures   
Joint arthroplasty  1  1/676 (0.15%)  1
Vascular disorders   
Aortic aneurysm  1  1/676 (0.15%)  1
Hypertension  1  4/676 (0.59%)  4
Raynaud's phenomenon  1  1/676 (0.15%)  1
Extremity necrosis  1  1/676 (0.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00503139     History of Changes
Other Study ID Numbers: 0881A1-4426
B1801045 ( Other Identifier: Alias Study Number )
First Submitted: July 16, 2007
First Posted: July 18, 2007
Results First Submitted: March 27, 2014
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017