Trial Outcomes & Findings for Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects (NCT NCT00706797)
NCT ID: NCT00706797
Last Updated: 2011-06-21
Results Overview
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) plus (+) erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
TERMINATED
PHASE4
141 participants
Baseline, Week 52
2011-06-21
Participant Flow
141 participants were randomized, 1 participant performed all the planned visits, and 140 participants were discontinued before completion of the study; 115 participants prematurely withdrew due to discontinuation of the study by the sponsor.
Participant milestones
| Measure |
Usual Care
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
|
ETN + MTX
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
71
|
|
Overall Study
Safety Population
|
63
|
71
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
69
|
71
|
Reasons for withdrawal
| Measure |
Usual Care
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
|
ETN + MTX
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Discontinuation of study by sponsor
|
52
|
63
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
Baseline characteristics by cohort
| Measure |
Usual Care
n=63 Participants
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
|
ETN + MTX
n=71 Participants
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: Modified intent-to-treat (mITT) population including all participants with an erosion at randomization confirmed by the blinded expert assessor, received at least 1 dose of subject treatment, and had data for randomization and 1 post randomization X-ray. Efficacy data not analyzed due to early termination of the study.
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) plus (+) erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Last observation carried forward (LOCF)Population: mITT; efficacy data not analyzed due to early termination of the study.
Radiographic non-progression determined based on TSS change \<0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score \>5.1=higher disease activity; \<3.2=low disease activity; \<2.6=clinical remission. Achievement of \>1.2 improvement defined as decrease in DAS28 \>1.2 (change in DAS28 \< -1.2).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, and Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score \>5.10=higher disease activity; \<3.20=low disease activity; \<2.60=clinical remission.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, and Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score \>5.10=higher disease activity; \<3.20=low disease activity; \<2.60=clinical remission.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, and Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant's assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score \>5.10=higher disease activity; \<3.20=low disease activity; \<2.60=clinical remission. DAS28 response of \>0.6 defined as decrease in DAS28 \>0.6 (change in DAS28 \< -0.6).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as \>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of \>0.6 but ≤1.2 and DAS attained during follow-up of \>5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
American College of Rheumatology 20% (ACR20) response: responder = ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
American College of Rheumatology 50% (ACR50) response: responder = ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
American College of Rheumatology 70% (ACR70) response: responder = ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 24, Week 40, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 24, Week 40, Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, and Week 52Population: mITT; efficacy data not analyzed due to early termination of the study.
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
ETN + MTX
Serious adverse events
| Measure |
Usual Care
n=63 participants at risk
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
|
ETN + MTX
n=71 participants at risk
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
1.6%
1/63
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.6%
1/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/63
|
0.00%
0/71
|
|
Infections and infestations
Bronchopneumonia
|
1.6%
1/63
|
0.00%
0/71
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63
|
2.8%
2/71
|
|
Infections and infestations
Pyothorax
|
0.00%
0/63
|
1.4%
1/71
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/63
|
1.4%
1/71
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/63
|
1.4%
1/71
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/63
|
1.4%
1/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/63
|
2.8%
2/71
|
Other adverse events
| Measure |
Usual Care
n=63 participants at risk
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
|
ETN + MTX
n=71 participants at risk
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/63
|
0.00%
0/71
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/63
|
0.00%
0/71
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/63
|
1.4%
1/71
|
|
Cardiac disorders
Mitral valve incompetence
|
1.6%
1/63
|
0.00%
0/71
|
|
Cardiac disorders
Palpitations
|
0.00%
0/63
|
1.4%
1/71
|
|
Cardiac disorders
Sick sinus syndrome
|
1.6%
1/63
|
0.00%
0/71
|
|
Endocrine disorders
Goitre
|
0.00%
0/63
|
1.4%
1/71
|
|
Eye disorders
Astigmatism
|
1.6%
1/63
|
0.00%
0/71
|
|
Eye disorders
Cataract
|
1.6%
1/63
|
1.4%
1/71
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/63
|
2.8%
2/71
|
|
Eye disorders
Myopia
|
0.00%
0/63
|
1.4%
1/71
|
|
Eye disorders
Retinopathy
|
0.00%
0/63
|
1.4%
1/71
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
2/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
3.2%
2/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/63
|
1.4%
1/71
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/63
|
1.4%
1/71
|
|
Gastrointestinal disorders
Enteritis
|
1.6%
1/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Nausea
|
4.8%
3/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Reflux gastritis
|
1.6%
1/63
|
0.00%
0/71
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/63
|
1.4%
1/71
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/63
|
1.4%
1/71
|
|
General disorders
Asthenia
|
1.6%
1/63
|
2.8%
2/71
|
|
General disorders
Fatigue
|
0.00%
0/63
|
2.8%
2/71
|
|
General disorders
Injection site erythema
|
0.00%
0/63
|
1.4%
1/71
|
|
General disorders
Injection site joint inflammation
|
0.00%
0/63
|
1.4%
1/71
|
|
General disorders
Injection site pruritus
|
0.00%
0/63
|
1.4%
1/71
|
|
General disorders
Injection site rash
|
0.00%
0/63
|
5.6%
4/71
|
|
General disorders
Injection site reaction
|
0.00%
0/63
|
4.2%
3/71
|
|
General disorders
Oedema peripheral
|
1.6%
1/63
|
1.4%
1/71
|
|
General disorders
Pyrexia
|
1.6%
1/63
|
0.00%
0/71
|
|
Hepatobiliary disorders
Hepatic cyst
|
1.6%
1/63
|
0.00%
0/71
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/63
|
1.4%
1/71
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/63
|
1.4%
1/71
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/63
|
1.4%
1/71
|
|
Infections and infestations
Bronchitis
|
1.6%
1/63
|
1.4%
1/71
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/63
|
1.4%
1/71
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/63
|
0.00%
0/71
|
|
Infections and infestations
Helicobacter infection
|
1.6%
1/63
|
0.00%
0/71
|
|
Infections and infestations
Herpes zoster
|
1.6%
1/63
|
0.00%
0/71
|
|
Infections and infestations
Influenza
|
1.6%
1/63
|
1.4%
1/71
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/63
|
4.2%
3/71
|
|
Infections and infestations
Oral herpes
|
0.00%
0/63
|
1.4%
1/71
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63
|
1.4%
1/71
|
|
Infections and infestations
Rash pustular
|
1.6%
1/63
|
0.00%
0/71
|
|
Infections and infestations
Rhinitis
|
0.00%
0/63
|
2.8%
2/71
|
|
Infections and infestations
Tooth infection
|
0.00%
0/63
|
1.4%
1/71
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/63
|
4.2%
3/71
|
|
Infections and infestations
Urinary tract infection
|
3.2%
2/63
|
2.8%
2/71
|
|
Infections and infestations
Viral infection
|
0.00%
0/63
|
1.4%
1/71
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
1/63
|
0.00%
0/71
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/63
|
1.4%
1/71
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/63
|
0.00%
0/71
|
|
Investigations
Blood urea increased
|
1.6%
1/63
|
0.00%
0/71
|
|
Investigations
Hepatitis b dna decreased
|
0.00%
0/63
|
1.4%
1/71
|
|
Investigations
Transaminases abnormal
|
0.00%
0/63
|
1.4%
1/71
|
|
Investigations
Transaminases increased
|
1.6%
1/63
|
2.8%
2/71
|
|
Investigations
Weight decreased
|
1.6%
1/63
|
0.00%
0/71
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/63
|
1.4%
1/71
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.6%
1/63
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/63
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
1/63
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/63
|
2.8%
2/71
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/63
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.6%
1/63
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/63
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/63
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.6%
1/63
|
1.4%
1/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/63
|
1.4%
1/71
|
|
Nervous system disorders
Dizziness
|
1.6%
1/63
|
0.00%
0/71
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/63
|
1.4%
1/71
|
|
Nervous system disorders
Headache
|
1.6%
1/63
|
1.4%
1/71
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/63
|
2.8%
2/71
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/63
|
1.4%
1/71
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/63
|
1.4%
1/71
|
|
Psychiatric disorders
Agitation
|
0.00%
0/63
|
1.4%
1/71
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/63
|
2.8%
2/71
|
|
Psychiatric disorders
Depression
|
1.6%
1/63
|
0.00%
0/71
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/63
|
1.4%
1/71
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/63
|
0.00%
0/71
|
|
Renal and urinary disorders
Leukocyturia
|
1.6%
1/63
|
0.00%
0/71
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/63
|
0.00%
0/71
|
|
Renal and urinary disorders
Nephropathy toxic
|
1.6%
1/63
|
0.00%
0/71
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/63
|
1.4%
1/71
|
|
Reproductive system and breast disorders
Breast pain
|
1.6%
1/63
|
0.00%
0/71
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.6%
1/63
|
0.00%
0/71
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/63
|
1.4%
1/71
|
|
Reproductive system and breast disorders
Thelitis
|
0.00%
0/63
|
1.4%
1/71
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/63
|
1.4%
1/71
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/63
|
1.4%
1/71
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.2%
2/63
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/63
|
1.4%
1/71
|
|
Skin and subcutaneous tissue disorders
Melanosis
|
0.00%
0/63
|
1.4%
1/71
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/63
|
1.4%
1/71
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/63
|
1.4%
1/71
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.6%
1/63
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/63
|
1.4%
1/71
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.6%
1/63
|
0.00%
0/71
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/63
|
1.4%
1/71
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/63
|
1.4%
1/71
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/63
|
1.4%
1/71
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/63
|
1.4%
1/71
|
|
Vascular disorders
Flushing
|
1.6%
1/63
|
0.00%
0/71
|
|
Vascular disorders
Haematoma
|
1.6%
1/63
|
0.00%
0/71
|
|
Vascular disorders
Hot flush
|
0.00%
0/63
|
1.4%
1/71
|
|
Vascular disorders
Hypertension
|
6.3%
4/63
|
2.8%
2/71
|
|
Vascular disorders
Hypotension
|
1.6%
1/63
|
0.00%
0/71
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER