Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195494
First received: September 13, 2005
Last updated: August 1, 2012
Last verified: August 2012
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Results First Received: March 31, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Rheumatoid Arthritis |
| Interventions: |
Drug: Etanercept Drug: Methotrexate Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were recruited worldwide from November 2004 to February 2006. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Participants were randomly assigned equally to 1 of 4 blinded treatment groups: Group (G) 1a received the combination of etanercept (E) and methotrexate (M) in year Y1 and Y2. G1b received the combination of E and M in Y1 and E alone in Y2. G2a received M alone in Y1 and the combination of E and M in Y2. G2b received M alone in Y1 and Y2. |
Reporting Groups
| Description | |
|---|---|
| Year 1 E+M / Year 2 E+M |
Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. |
| Year 1 M / Year 2 E+M |
Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. |
| Year 1 E+M / Year 2 E | Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites). |
| Year 1 M / Year 2 M |
Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. |
| Year 1 M+Placebo |
Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites. MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. |
| Year 1 E+M |
Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. |
Participant Flow for 2 periods
Period 1: Year 1
| Year 1 E+M / Year 2 E+M | Year 1 M / Year 2 E+M | Year 1 E+M / Year 2 E | Year 1 M / Year 2 M | Year 1 M+Placebo | Year 1 E+M | |
|---|---|---|---|---|---|---|
| STARTED | 0 | 0 | 0 | 0 | 268 | 274 |
| COMPLETED | 0 | 0 | 0 | 0 | 189 | 221 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 79 | 53 |
| Adverse Event | 0 | 0 | 0 | 0 | 34 | 27 |
| System Toxicity | 0 | 0 | 0 | 0 | 0 | 1 |
| Lack of Efficacy | 0 | 0 | 0 | 0 | 24 | 9 |
| Compliance | 0 | 0 | 0 | 0 | 5 | 1 |
| Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Missed >4 consecutive doses | 0 | 0 | 0 | 0 | 3 | 2 |
| Protocol deviation | 0 | 0 | 0 | 0 | 2 | 3 |
| Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 0 | 0 | 0 | 0 | 8 | 9 |
| Protocol Violation | 0 | 0 | 0 | 0 | 1 | 1 |
Period 2: Year 2
| Year 1 E+M / Year 2 E+M | Year 1 M / Year 2 E+M | Year 1 E+M / Year 2 E | Year 1 M / Year 2 M | Year 1 M+Placebo | Year 1 E+M | |
|---|---|---|---|---|---|---|
| STARTED | 111 [1] | 90 | 111 [1] | 99 | 0 | 0 |
| COMPLETED | 104 | 74 | 93 | 76 | 0 | 0 |
| NOT COMPLETED | 7 | 16 | 18 | 23 | 0 | 0 |
| Adverse Event | 3 | 7 | 5 | 9 | 0 | 0 |
| Lack of Efficacy | 0 | 1 | 7 | 7 | 0 | 0 |
| Compliance | 1 | 0 | 0 | 2 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 1 | 1 | 0 | 0 |
| Missed >4 consecutive doses | 1 | 1 | 1 | 0 | 0 | 0 |
| Protocol deviation | 0 | 1 | 0 | 0 | 0 | 0 |
| Physician Decision | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrawal by Subject | 1 | 5 | 4 | 3 | 0 | 0 |
| System toxicity | 0 | 0 | 0 | 1 | 0 | 0 |
| [1] | A patient with Year 1 termination had taken drug briefly during Year 2 and thus counted in the data. |
|---|
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Year 1 M+Placebo |
Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites. MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. |
| Year 1 E+M |
Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. |
| Total | Total of all reporting groups |
Baseline Measures
| Year 1 M+Placebo | Year 1 E+M | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
268 | 274 | 542 |
|
Age
[1] [units: years] Median ( Full Range ) |
51.50
( 20.00 to 84.00 ) |
52.50
( 18.00 to 82.00 ) |
52.00
( 18.00 to 84.00 ) |
|
Gender
[2] [units: Year 1 participants] |
|||
| Female | 194 | 204 | 398 |
| Male | 74 | 70 | 144 |
| [1] | Year 1 Overall Number of Baseline Participants is 542 |
|---|---|
| [2] | Year 1 participants collected from Arms M and E+M equal the stated overall participant population of 542. 411 of those participants were then entered into Year 2 Arms E+M/E+M, M/M+E, E+M/E, M/M. This measure provides the gender population for Year 1 only in order to accurately reflect the overall baseline population of 542. |
Outcome Measures
| 1. Primary: | The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. [ Time Frame: 12 months ] |
| 2. Primary: | Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. [ Time Frame: 12 months ] |
| 3. Secondary: | Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death [ Time Frame: 12 and 24 months ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Year 1 E+M / Year 2 E+M |
Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. |
| Year 1 M / Year 2 E+M |
Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. |
| Year 1 E+M / Year 2 E | Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites). |
| Year 1 M / Year 2 M |
Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs). No reduction of MTX dose is permitted in year two. |
| Year 1 M+Placebo |
Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites. MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. |
| Year 1 E+M |
Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8. |
Serious Adverse Events
| Year 1 E+M / Year 2 E+M | Year 1 M / Year 2 E+M | Year 1 E+M / Year 2 E | Year 1 M / Year 2 M | Year 1 M+Placebo | Year 1 E+M | |
|---|---|---|---|---|---|---|
| Total, serious adverse events | ||||||
| # participants affected | 8 | 11 | 10 | 12 | 34 | 33 |
| Cardiac disorders | ||||||
| Angina unstable * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Arrhythmia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Aterial fibrillation * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Myocardial infarction * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Pericarditis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Ventricular tachycardia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Aortic valve stenosis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Atrio ventricular block * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Mitral valve incompetence * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Ear and labyrinth disorders | ||||||
| Vertigo * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Eye disorders | ||||||
| Photophobia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Gastrointestinal disorders | ||||||
| Appendicitis perforated * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Gastritis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 1/274 (0.36%) |
| General gastrointestinal disorder * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Gastrointestinal haemorrhage * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Mechanical ileus * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Vomiting * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Abdominal pain upper * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Inguinal hernia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| General disorders | ||||||
| Chest pain * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 1/274 (0.36%) |
| General physical health deterioration * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Systemic inflammatory response system * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Hepatobiliary disorders | ||||||
| Cholelithiasis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 2/274 (0.73%) |
| Gallbladder disorder * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Infections and infestations | ||||||
| Acute sinusitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Bronchitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Chronic sinusitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Diverticulitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Gastroenteritis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Herpes zoster * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Lung infection * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Lyme disease * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Nasopharyngitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Pneumonia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 1/99 (1.01%) | 1/268 (0.37%) | 1/274 (0.36%) |
| Septic athritis staphylococcal * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Skin infection * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Streptococcal infection * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Bursitis infected staphylococcal * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Pneumonia streptococcal * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Tonsillitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Injury, poisoning and procedural complications | ||||||
| Accidental overdose * | ||||||
| # participants affected / at risk | 2/111 (1.80%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Joint injury * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Overdose * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Pelvic fracture * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Procedural pain * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Radius fracture * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Spinal fracture * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Concussion * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Device failure * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Fall * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Ligament injury * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Skull fractured base * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Investigations | ||||||
| Blood alkaline phosphatase increased * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Hepatic enzyme increased * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Transaminases increased * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Metabolism and nutrition disorders | ||||||
| Diabetes mellitus * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Hyponatraemia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthritis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Haemarthrosis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Intervertebral disc disorder * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Intervetebral disc protrusion * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 2/274 (0.73%) |
| Osteoarthritis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 2/268 (0.75%) | 0/274 (0.00%) |
| Rheumatoid arthritis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 5/268 (1.87%) | 2/274 (0.73%) |
| Arthropathy * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Spondylolisthesis acquired * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal cell carcinoma * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 1/111 (0.90%) | 1/99 (1.01%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Bowen's disease * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Breast cancer * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 3/268 (1.12%) | 0/274 (0.00%) |
| Chronic lymphocytic leukamia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Prostate cancer * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Tongue neoplasm * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Gastrointestinal carcinoma * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Lung cancer metastatic * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Malignant melanoma of sights other than skin * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Metastases to lung * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Pancreatic carcinoma * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Transitional cell carcinoma * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Nervous system disorders | ||||||
| Cerebral haemorrhage * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Headache * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Paraesthesia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Syncope * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Syncope vasovagal * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Cerebellar infarction * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Cerebral infarction * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Cerebrovascular accident * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Hydrocephalus * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Sciatica * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Psychiatric disorders | ||||||
| Anxiety * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Sleep disorder * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Confusional state * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Renal and urinary disorders * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Renal colic * | ||||||
| # participants affected / at risk | 1/111 (0.90%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Renal and urinary disorders | ||||||
| Renal failure * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Urinary retention * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Reproductive system and breast disorders | ||||||
| Testicular torsion * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Vaginal prolapse * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Idiopathic pulmonary fibrosis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Interstitial lung disease * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 2/274 (0.73%) |
| Pneumonitis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Pneumothorax * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Dyspnoea * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 1/90 (1.11%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Pulmonary embolism * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Skin and subcutaneous tissue disorders | ||||||
| Hyperhidrosis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Surgical and medical procedures | ||||||
| Hip arthroplasty * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 2/268 (0.75%) | 0/274 (0.00%) |
| Hospitalisation * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Cholecystectomy * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Haemorrhoid operation * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 1/111 (0.90%) | 0/99 (0.00%) | 0/268 (0.00%) | 0/274 (0.00%) |
| Vascular disorders | ||||||
| Deep vein thrombosis * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Infarction * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 0/268 (0.00%) | 1/274 (0.36%) |
| Ischaemia * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 0/99 (0.00%) | 1/268 (0.37%) | 0/274 (0.00%) |
| Aneurysm * | ||||||
| # participants affected / at risk | 0/111 (0.00%) | 0/90 (0.00%) | 0/111 (0.00%) | 1/99 (1.01%) | 0/268 (0.00%) | 0/274 (0.00%) |
| * | Events were collected by non-systematic assessment |
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Other Adverse Events
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer
Publications automatically indexed to this study:
| 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. | ||||||
The agreement is:
|
Limitations and Caveats
| 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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| No text entered. |
Results Point of Contact:
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer
Publications automatically indexed to this study:
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00195494 History of Changes |
| Other Study ID Numbers: | 0881A-101548 |
| Study First Received: | September 13, 2005 |
| Results First Received: | March 31, 2009 |
| Last Updated: | August 1, 2012 |
| Health Authority: | European Union: European Medicines Agency |