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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Condition: |
Myocardial Infarction |
| Interventions: |
Drug: abciximab placebo; reteplase placebo, abciximab, abciximab Drug: Abciximab; reteplase; abciximab placebo; abciximab Drug: abciximab; reteplase placebo; abciximab placebo; abciximab |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| A total of 2,452 subjects from 20 countries were randomized in this study. The FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) study began enrollment in August 2002. It was planned that approximately 3,000 subjects would be enrolled. Because of enrollment difficulty, subject enrollment was stopped on 30 Dec 2006. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Primary PCI Group | Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI) |
| Abciximab Facilitated PCI Group | Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI |
| Reteplase/Abciximab Facilitated PCI Group | Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI |
| Primary PCI Group | Abciximab Facilitated PCI Group | Reteplase/Abciximab Facilitated PCI Group | |
|---|---|---|---|
| STARTED | 806 | 818 | 828 |
| COMPLETED | 793[1] | 810[2] | 813[3] |
| NOT COMPLETED | 13 | 8 | 15 |
| [1] | The number completed includes subjects who died or were seen for a visit within specified window. |
|---|---|
| [2] | The number completed includes subjects who died or were seen for a visit within specified window. |
| [3] | The number completed includes subjects who died or were seen for a visit within specified window. |
| Primary PCI Group | Abciximab Facilitated PCI Group | Reteplase/Abciximab Facilitated PCI Group | |
|---|---|---|---|
| STARTED | 806[1] | 818[2] | 828[3] |
| COMPLETED | 787[4] | 804[5] | 816[6] |
| NOT COMPLETED | 19 | 14 | 12 |
| [1] | This is the number of participants that were originally randomized to the trial. |
|---|---|
| [2] | This is the number of participants that were originally randomized to the trial. |
| [3] | This is the number of participants that were originally randomized to the trial. |
| [4] | The number completed includes subjects who died or were seen for a visit within specified window. |
| [5] | The number completed includes subjects who died or were seen for a visit within specified window. |
| [6] | The number completed includes subjects who died or were seen for a visit within specified window |
Baseline Characteristics
| Description | |
|---|---|
| Primary PCI Group | Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI) |
| Abciximab Facilitated PCI Group | Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI |
| Reteplase/Abciximab Facilitated PCI Group | Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI |
| Primary PCI Group | Abciximab Facilitated PCI Group | Reteplase/Abciximab Facilitated PCI Group | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
806 | 818 | 828 | 2452 |
|
Age [units: years] Mean ± Standard Deviation |
62.5 ± 11.4 | 61.9 ± 11.8 | 62.6 ± 11.4 | 62.4 ± 11.5 |
|
Gender [units: participants] |
||||
| Female | 207 | 216 | 219 | 642 |
| Male | 599 | 602 | 609 | 1810 |
Outcome Measures
| 1. Primary: | The Composite of All-Cause Mortality or Complications of MI at 90 Days. [ 90 days ] |
| 2. Secondary: | Complications of MI as Defined in the Primary Outcome Measure Through 90 Days [ 90 Days ] |
| 3. Secondary: | All-Cause Mortality Through 90 Days [ 90 days ] |
| 4. Secondary: | Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization [ 60 to 90 minutes ] |
| 5. Secondary: | All-Cause Mortality Through 1 Year [ 1 year ] |
| 6. Other Pre-specified: | Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7 [ Discharge/Day 7 ] |
| 7. Other Pre-specified: | Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7 [ Discharge/Day 7 ] |
| 8. Other Pre-specified: | Subjects With Severe Thrombocytopenia Through Discharge/Day 7 [ Discharge/Day 7 ] |
| 9. Other Pre-specified: | Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7 [ Discharge/Day 7 ] |
| 10. Other Pre-specified: | Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7 [ Discharge/Day 7 ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Description | |
|---|---|
| Primary PCI Group | Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI) |
| Abciximab Facilitated PCI Group | Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI |
| Reteplase/Abciximab Facilitated PCI Group | Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI |
| Primary PCI Group | Abciximab Facilitated PCI Group | Reteplase/Abciximab Facilitated PCI Group | |
|---|---|---|---|
| Total, serious adverse events | |||
| # participants affected | 159 | 182 | 175 |
| Blood and lymphatic system disorders | |||
| Thrombocytopenia † A # participants affected / at risk |
1/795 (0.13%) |
3/805 (0.37%) |
1/814 (0.12%) |
| Hemoglobin decreased † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Anemia † A # participants affected / at risk |
1/795 (0.13%) |
3/805 (0.37%) |
0/814 (0.00%) |
| Anemia iron deficiency † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Anemia microcytic † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Leukopenia † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Cardiac disorders | |||
| Coronary stenosis † A # participants affected / at risk |
23/795 (2.89%) |
38/805 (4.72%) |
27/814 (3.32%) |
| Shock cardiogenic † A # participants affected / at risk |
4/795 (0.50%) |
9/805 (1.12%) |
13/814 (1.60%) |
| Unstable angina † A # participants affected / at risk |
4/795 (0.50%) |
2/805 (0.25%) |
6/814 (0.74%) |
| Myocardial infarction † A # participants affected / at risk |
6/795 (0.75%) |
10/805 (1.24%) |
5/814 (0.61%) |
| Angina pectoris † A # participants affected / at risk |
2/795 (0.25%) |
3/805 (0.37%) |
4/814 (0.49%) |
| Congestive heart failure † A # participants affected / at risk |
0/795 (0.00%) |
3/805 (0.37%) |
4/814 (0.49%) |
| Myocardial ischemia † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
4/814 (0.49%) |
| Cardiac failure † A # participants affected / at risk |
3/795 (0.38%) |
5/805 (0.62%) |
3/814 (0.37%) |
| Acute myocardial infarction † A # participants affected / at risk |
0/795 (0.00%) |
3/805 (0.37%) |
2/814 (0.25%) |
| Left ventricular dysfunction † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Chronic congestive heart failure † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Coronary artery dissection † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Heart disorder † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Myocardial rupture † A # participants affected / at risk |
2/795 (0.25%) |
2/805 (0.25%) |
1/814 (0.12%) |
| Pericarditis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Spiral coronary artery dissection † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Stable angina pectoris † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Tricuspid insufficiency † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Ventricular aneurysm † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Anginal pain † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Aortic stenosis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Cardiac tamponade † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Coronary artery occlusion † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Coronary artery perforation † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Coronary in-stent restenosis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Coronary restenosis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Endocarditis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Left ventricular ejection fraction decreased † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Mitral insufficiency † A # participants affected / at risk |
2/795 (0.25%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Mitral regurgitation † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Pericardial effusion † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Ventricular septal defect † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Fibrillation ventricular † A # participants affected / at risk |
26/795 (3.27%) |
21/805 (2.61%) |
16/814 (1.97%) |
| Cardiac arrest † A # participants affected / at risk |
5/795 (0.63%) |
2/805 (0.25%) |
3/814 (0.37%) |
| Tachycardia ventricular † A # participants affected / at risk |
2/795 (0.25%) |
5/805 (0.62%) |
2/814 (0.25%) |
| AV block complete † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| AV block third degree † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Junctional bradycardia † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Nonsustained ventricular tachycardia † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Sinus bradycardia † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Arrhythmia supraventricular † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Arrhythmia ventricular † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Asystolia † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Atrial fibrillation † A # participants affected / at risk |
4/795 (0.50%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Atrial fibrillation paroxysmal † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Atrial flutter † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| AV block second degree † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Bradycardia † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Cardiac arrhythmia nos † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Cardiac rhythm disturbance † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Cardiopulmonary arrest † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Electromechanical dissociation † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Intraventricular conduction defect † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Tachycardia atrial paroxysmal † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Ventricular bigeminy † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Ventricular febrillation paroxysm † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Atherosclerosis † A # participants affected / at risk |
14/795 (1.76%) |
4/805 (0.50%) |
14/814 (1.72%) |
| Hypotension † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Syncope † A # participants affected / at risk |
1/795 (0.13%) |
2/805 (0.25%) |
2/814 (0.25%) |
| Blood pressure high † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Hypertension † A # participants affected / at risk |
2/795 (0.25%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Transient hypotension † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Collapse † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Hypertension arterial † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Hypovolemic shock † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Septic shock † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Shock † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Endocrine disorders | |||
| Hyperthyroidism † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Gastrointestinal disorders | |||
| Abdominal pain † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Diarrhea † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Diverticulitis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Dysphagia † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Esophageal reflux † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Gastritis † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Ileus † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Intestinal Polyp † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Nontropical sprue † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pancreatitis acute † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Preploric ulcer † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Digestion impaired † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Duodenal ulcer † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Epigastric pain † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Esophagitis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Gastric ulcer † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Gastroesophageal reflux disease † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Intestinal obstruction † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Irritable bowel syndrome † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Stomach pain † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Stomach upset † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| General disorders | |||
| Chest pain † A # participants affected / at risk |
10/795 (1.26%) |
19/805 (2.36%) |
12/814 (1.47%) |
| Death † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
1/814 (0.12%) |
| Non-anginal pain † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Non-ischemic chest pain † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Allergic reaction † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Allergic reaction to diagnostic agent † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Incarcerated abdonimal hernia † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Inguinal hernia † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Interstitial fluid increased † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Intolerance induced † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Malaise † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Musculoskeletal pain † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Nontoxic drug overdose † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Pain † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Hepatobiliary disorders | |||
| Cholecystitis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Gall bladder distention † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Hepatobiliary dysfunction † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Jaundice † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Infections and infestations | |||
| Cellulitis † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Fever † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Sepsis † A # participants affected / at risk |
1/795 (0.13%) |
2/805 (0.25%) |
1/814 (0.12%) |
| Infection bacterial † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Influenza † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Urosepsis † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Wound healing impaired † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Wound infection † A # participants affected / at risk |
2/795 (0.25%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Metabolism and nutrition disorders | |||
| Hypercholesterolemia † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Adult onset diabetes mellitus † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Dehydration † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Diabetes mellitus † A # participants affected / at risk |
2/795 (0.25%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Hyponatremia † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Musculoskeletal and connective tissue disorders | |||
| Aseptic necrosis bone † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Bone fracture † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Myalgia † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Skeletal pain † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Arthritis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Synovitis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |||
| Carcinoma † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Prostate cancer † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pulmonary cancer † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pulmonary carcinoma † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Rectal adenocarcinoma † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Rectal carcinoma † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Adenocarcinoma nos † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Breast carcinoma † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Ovarian cyst malignant † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Renal carcinoma † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Nervous system disorders | |||
| Epilepsy grand mal † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pre-syncope † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Carpal tunnel syndrome † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Coma † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Dizziness † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Vasovagal reaction † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Psychiatric disorders | |||
| Anxiety † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Delirium tremens † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Renal and urinary disorders | |||
| Acute renal failure † A # participants affected / at risk |
2/795 (0.25%) |
1/805 (0.12%) |
4/814 (0.49%) |
| Urinary tract infection † A # participants affected / at risk |
1/795 (0.13%) |
2/805 (0.25%) |
2/814 (0.25%) |
| Chronic renal failure † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Creatinine increased † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Renal function decreased † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Urethral disorder nos † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Urinary retention † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Acute renal insufficiency † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Bladder stricture † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Nephritis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Pyelonephritis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Renal failure † A # participants affected / at risk |
3/795 (0.38%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Renal insufficiency † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Respiratory, thoracic and mediastinal disorders | |||
| Pneumonia † A # participants affected / at risk |
7/795 (0.88%) |
8/805 (0.99%) |
7/814 (0.86%) |
| Bronchopneumonia † A # participants affected / at risk |
2/795 (0.25%) |
2/805 (0.25%) |
3/814 (0.37%) |
| Pulmonary edema † A # participants affected / at risk |
3/795 (0.38%) |
4/805 (0.50%) |
3/814 (0.37%) |
| Breath shortness † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Respiratory arrest † A # participants affected / at risk |
0/795 (0.00%) |
2/805 (0.25%) |
2/814 (0.25%) |
| Respiratory failure † A # participants affected / at risk |
1/795 (0.13%) |
3/805 (0.37%) |
2/814 (0.25%) |
| Aspiration pneumonia † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Breathing difficult † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Bronchitis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Chronic obstructive pulmonary disease † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Coughing † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pleural effusion † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Pleuritis † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pneumothorax † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Respiratory disorder † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Repiratory tract infection † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Respiratory tract lesion † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Adult respiratory distress syndrome † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Breathlessness † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Dyspnea † A # participants affected / at risk |
2/795 (0.25%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Emphysema † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Lower respiratory tract infection † A # participants affected / at risk |
1/795 (0.13%) |
2/805 (0.25%) |
0/814 (0.00%) |
| Pleural exudate † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Pneumonia interstitial † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Skin and subcutaneous tissue disorders | |||
| Eruption † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Vascular disorders | |||
| Hemorrhagic stroke † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Gastric hemorrhage † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| GI hemorrhage † A # participants affected / at risk |
2/795 (0.25%) |
1/805 (0.12%) |
1/814 (0.12%) |
| GI hemorrhage - upper † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Hematoma † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Hemoptysis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Hemorrhage nos † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Hematemesis † A # participants affected / at risk |
2/795 (0.25%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Hemorrhage rectum † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Pulmonary hemorrhage † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Puncture site hematoma † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Retroperitoneal hemorrhage (type unknown) † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Vomiting blood † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Stroke † A # participants affected / at risk |
3/795 (0.38%) |
2/805 (0.25%) |
3/814 (0.37%) |
| Claudication intermittent † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Arterial stenosis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Pseudoaneurysm † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
1/814 (0.12%) |
| Vasculitis † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Cerebral infarction † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Cerebrovascular accident † A # participants affected / at risk |
1/795 (0.13%) |
3/805 (0.37%) |
0/814 (0.00%) |
| Claudication † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Extracardiact arterial aneurysm † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Peripheral ischemia † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Phlebitis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Transient ischemic attack † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Left ventricular thrombus † A # participants affected / at risk |
2/795 (0.25%) |
2/805 (0.25%) |
2/814 (0.25%) |
| Thrombosis coronary artery † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
2/814 (0.25%) |
| Thrombosis cardiac chamber † A # participants affected / at risk |
0/795 (0.00%) |
0/805 (0.00%) |
1/814 (0.12%) |
| Atheroembolism limb † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Embolism pulmonary † A # participants affected / at risk |
2/795 (0.25%) |
3/805 (0.37%) |
0/814 (0.00%) |
| Phlebothrombosis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Thrombophlebitis † A # participants affected / at risk |
0/795 (0.00%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Thrombosis venous deep † A # participants affected / at risk |
1/795 (0.13%) |
1/805 (0.12%) |
0/814 (0.00%) |
| Thrombosis † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| Venous thrombosis leg † A # participants affected / at risk |
1/795 (0.13%) |
0/805 (0.00%) |
0/814 (0.00%) |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, WHOART |
Other Adverse Events
More Information
| 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 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 |
|---|
| Some AEs were collected separately per protocol and are reported as “Other Pre-Specified Outcomes Measures”. |
| Responsible Party: | Centocor, Inc. ( Executive Director Clinical Research ) |
| Study ID Numbers: | CR005410, CR005410, FINESSE |
| Study First Received: | September 24, 2002 |
| Results First Received: | March 26, 2009 |
| Last Updated: | June 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00046228 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
