Trial Outcomes & Findings for Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan (NCT NCT00503139)
NCT ID: NCT00503139
Last Updated: 2017-02-28
Results Overview
Recruitment status
COMPLETED
Target enrollment
684 participants
Primary outcome timeframe
3 years
Results posted on
2017-02-28
Participant Flow
Participant milestones
| Measure |
Etanercept (Genetical Recombination)
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 Study
STARTED
|
684
|
|
Overall Study
COMPLETED
|
676
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Etanercept (Genetical Recombination)
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 Study
Case Report Forms were not collected
|
4
|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan
Baseline characteristics by cohort
| Measure |
Etanercept (Genetical Recombination)
n=676 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Age, Customized
<65 years
|
454 Participants
n=99 Participants
|
|
Age, Customized
>=65 years
|
222 Participants
n=99 Participants
|
|
Gender
Female
|
559 Participants
n=99 Participants
|
|
Gender
Male
|
117 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=676 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Number of Participants in Safety Analysis Population of Etanercept
1 to 2 years
|
475 Participants
|
|
Number of Participants in Safety Analysis Population of Etanercept
2 to 3 years
|
372 Participants
|
|
Number of Participants in Safety Analysis Population of Etanercept
Within 6 months
|
676 Participants
|
|
Number of Participants in Safety Analysis Population of Etanercept
6 to 12 months
|
561 Participants
|
|
Number of Participants in Safety Analysis Population of Etanercept
Within 1 year
|
676 Participants
|
|
Number of Participants in Safety Analysis Population of Etanercept
3 years or more
|
176 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=676 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
Within 6 months (N=676)
|
117 Participants
|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
6 to 12 months (N=561)
|
84 Participants
|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
Within 1 year (N=676)
|
184 Participants
|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
1 to 2 years (N=475)
|
90 Participants
|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
2 to 3 years (N=372)
|
43 Participants
|
|
Number of Participants With Treatment Related Adverse Events of Etanercept
3 years or more (N=176)
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=676 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
Within 6 months (N = 676)
|
12 Participants
|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
6 to 12 months (N = 561)
|
17 Participants
|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
Within 1 year (N = 676)
|
29 Participants
|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
3 years or more (N = 176)
|
0 Participants
|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
1 to 2 years (N = 475)
|
24 Participants
|
|
Number of Participants With Serious Treatment Related Adverse Events of Etanercept
2 to 3 years (N = 372)
|
13 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=676 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept
|
16 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=583 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
At 1.5 years (N = 576)
|
79.69 percentage of participants
Interval 76.17 to 82.9
|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
At 6 months (N = 533)
|
84.05 percentage of participants
Interval 80.66 to 87.06
|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
At 1 year (N = 566)
|
82.51 percentage of participants
Interval 79.12 to 85.55
|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
At 2 years (N = 577)
|
81.98 percentage of participants
Interval 78.59 to 85.03
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=583 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Modified Health Assessment Questionnaire (mHAQ) Score
At 6 months (N = 490)
|
0.45 Score
Standard Deviation 0.58
|
|
Modified Health Assessment Questionnaire (mHAQ) Score
At Baseline (N = 583)
|
0.82 Score
Standard Deviation 0.64
|
|
Modified Health Assessment Questionnaire (mHAQ) Score
At 1 year (N = 520)
|
0.46 Score
Standard Deviation 0.61
|
|
Modified Health Assessment Questionnaire (mHAQ) Score
At 1.5 years (N = 526)
|
0.45 Score
Standard Deviation 0.61
|
|
Modified Health Assessment Questionnaire (mHAQ) Score
At 2 years (N = 531)
|
0.46 Score
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=583 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Visual Analog Fatigue Scale (VAFS)
At Baseline (N = 583)
|
49.1 Score
Standard Deviation 27.1
|
|
Visual Analog Fatigue Scale (VAFS)
At 6 months (N = 477)
|
26.1 Score
Standard Deviation 22.6
|
|
Visual Analog Fatigue Scale (VAFS)
At 1 year (N = 509)
|
25.2 Score
Standard Deviation 22.8
|
|
Visual Analog Fatigue Scale (VAFS)
At 1.5 years (N = 513)
|
25.3 Score
Standard Deviation 23.2
|
|
Visual Analog Fatigue Scale (VAFS)
At 2 years (N = 518)
|
26.0 Score
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Etanercept (Genetical Recombination)
n=583 Participants
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
2 years (N = 577)
|
80.42 percentage of participants
Interval 76.94 to 83.58
|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
At 6 months (N = 533)
|
81.80 percentage of participants
Interval 78.26 to 84.99
|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
1 year (N = 566)
|
81.10 percentage of participants
Interval 77.62 to 84.24
|
|
European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (3/Erythrocyte Sedimentation Rate: ESR)
1.5 years (N = 576)
|
79.69 percentage of participants
Interval 76.17 to 82.9
|
Adverse Events
Etanercept (Genetical Recombination)
Serious events: 77 serious events
Other events: 261 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept (Genetical Recombination)
n=676 participants at risk
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Infections and infestations
Skin bacterial infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Arthritis bacterial
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Bone tuberculosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Abdominal abscess
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pneumonia bacterial
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Device related infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma uterus
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Immune system disorders
Anaphylactic shock
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Cerebral infarction
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Bacteraemia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Bronchitis
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Cellulitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Disseminated tuberculosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Diverticulitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Herpes zoster
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pharyngitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pneumonia
|
1.2%
8/676 • Number of events 8
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pyelonephritis acute
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Sepsis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Sinusitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Urinary tract infection
|
0.30%
2/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Viral infection
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Dyskinesia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Leukoencephalopathy
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Senile dementia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Cardiac disorders
Cardiac failure
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Vascular disorders
Venous thrombosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Vascular disorders
Aortic dissection rupture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.89%
6/676 • Number of events 6
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Pyrexia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Sudden death
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Sudden cardiac death
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Granulocyte count decreased
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Lymphocyte count decreased
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Surgical and medical procedures
Renal stone removal
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
Other adverse events
| Measure |
Etanercept (Genetical Recombination)
n=676 participants at risk
Participants who received etanercept (genetical recombination) 10 to 25 mg once daily (twice weekly) or 25 to 50 mg once daily (once weekly) subcutaneously.
|
|---|---|
|
Infections and infestations
Acute sinusitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Acute tonsillitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Bronchitis
|
2.8%
19/676 • Number of events 23
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Bronchopneumonia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Cellulitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Chronic sinusitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Cystitis
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Fungal skin infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Gastroenteritis
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Hepatitis C
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Herpes virus infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Herpes zoster
|
1.6%
11/676 • Number of events 11
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Influenza
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Nail candida
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
25/676 • Number of events 27
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Onychomycosis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Oral candidiasis
|
0.15%
1/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Otitis media
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Parotitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pharyngitis
|
1.0%
7/676 • Number of events 10
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pneumonia
|
0.89%
6/676 • Number of events 6
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Pyelonephritis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Rash pustular
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Sinusitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Tinea pedis
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Tonsillitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Upper respiratory tract infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Urinary tract infection
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Arthritis bacterial
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Enteritis infectious
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Genitourinary tract infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Respiratory tract infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Oral herpes
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Post procedural infection
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Infections and infestations
Infected dermal cyst
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytosis haematophagic
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
6/676 • Number of events 7
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Endocrine disorders
Adrenal insufficiency
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Lipid metabolism disorder
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.44%
3/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Psychiatric disorders
Insomnia
|
0.59%
4/676 • Number of events 5
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Convulsion
|
0.15%
1/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Dizziness
|
0.74%
5/676 • Number of events 5
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Headache
|
0.74%
5/676 • Number of events 5
The frequency of treatment related adverse events during the study
|
|
Nervous system disorders
Sciatica
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Cataract
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Conjunctivitis allergic
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Corneal erosion
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Erythema of eyelid
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Eyelid oedema
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Uveitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Visual acuity reduced
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Eye disorders
Eye pruritus
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Cardiac disorders
Arrhythmia
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Vascular disorders
Aortic aneurysm
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Vascular disorders
Hypertension
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Vascular disorders
Raynaud's phenomenon
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Vascular disorders
Extremity necrosis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.74%
5/676 • Number of events 5
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.8%
19/676 • Number of events 24
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Abdominal distension
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Colonic polyp
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Constipation
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
8/676 • Number of events 8
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Dry mouth
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Enterocolitis
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Glossitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Nausea
|
0.30%
2/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
7/676 • Number of events 7
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Submaxillary gland enlargement
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.7%
25/676 • Number of events 30
The frequency of treatment related adverse events during the study
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.44%
3/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Hepatobiliary disorders
Hepatitis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Hepatobiliary disorders
Liver disorder
|
0.74%
5/676 • Number of events 5
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
9/676 • Number of events 11
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
8/676 • Number of events 10
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
11/676 • Number of events 12
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
13/676 • Number of events 15
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Skin chapped
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.59%
4/676 • Number of events 7
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Pollakiuria
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Renal failure
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Urge incontinence
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Renal impairment
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Feeling abnormal
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Generalised oedema
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Injection site pain
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
General disorders
Injection site reaction
|
4.4%
30/676 • Number of events 31
The frequency of treatment related adverse events during the study
|
|
General disorders
Malaise
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
General disorders
Oedema
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Oedema peripheral
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
General disorders
Pyrexia
|
1.3%
9/676 • Number of events 11
The frequency of treatment related adverse events during the study
|
|
General disorders
Foreign body reaction
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Investigations
Aspartate aminotransferase increased
|
0.30%
2/676 • Number of events 2
The frequency of treatment related adverse events during the study
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Investigations
Blood urea increased
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Investigations
Laboratory test abnormal
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Liver function test abnormal
|
1.0%
7/676 • Number of events 7
The frequency of treatment related adverse events during the study
|
|
Investigations
Platelet count decreased
|
0.44%
3/676 • Number of events 3
The frequency of treatment related adverse events during the study
|
|
Investigations
White blood cell count decreased
|
1.0%
7/676 • Number of events 7
The frequency of treatment related adverse events during the study
|
|
Investigations
Blood beta-D-glucan increased
|
0.59%
4/676 • Number of events 4
The frequency of treatment related adverse events during the study
|
|
Investigations
Blood alkaline phosphatase increased
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Antinuclear antibody positive
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Hepatic enzyme increased
|
0.89%
6/676 • Number of events 6
The frequency of treatment related adverse events during the study
|
|
Investigations
DNA antibody positive
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Investigations
Cell marker increased
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.15%
1/676 • Number of events 1
The frequency of treatment related adverse events during the study
|
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