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See termination reason in detailed description.
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To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients of non ST elevation acute coronary syndromes who are planned to undergo coronary interventions (angioplasty or bypass surgery)
The study was prematurely discontinued on November 30, 2008 due to delay in meeting pre-defined protocol recruitment milestones. There were no safety concerns regarding the study in the decision to terminate the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalteparin ( Fragmin) | Drug | Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 | Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. | Baseline to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Stroke | Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma). | End of hospitalization, Day 30 |
| Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 001 | India | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Subjects participated in the study between 22 June 2007 and 30 December 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Dalteparin | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| FG001 | Arm B: Unfractioned Heparin (UFH) | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Dalteparin | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 | Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. | Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint. | Posted | Number | participants | Baseline to Day 30 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Dalteparin | 120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
This study was terminated due to insufficient recruitment of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017985 | Dalteparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Unfractionated heparin | Drug | Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]). |
|
Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization. |
| End of hospitalization, Day 30 |
| Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days | Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. | End of hospitalization, Day 30 |
| Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization | Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically. | End of hospitalization, Day 30 |
| Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria | Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%. | End of hospitalization, Day 30 |
| Hyderabad |
| Andhra Pradesh |
| 500 034 |
| India |
| Pfizer Investigational Site | Nagpur | Maharashtra | 440 012 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 001 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 004 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 001 | India |
| Pfizer Investigational Site | Coimbatore | Tamil Nadu | 641 014 | India |
| Pfizer Investigational Site | Karnataka | 560 034 | India |
| Lost to Follow-up |
|
| Other |
|
| Withdrawal by Subject |
|
| Withdrawal by Subject Prior to Treatment |
|
| Received Drug in Other Treatment Group |
|
| BG001 |
| Arm B: Unfractioned Heparin (UFH) |
Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Arm B: Unfractioned Heparin (UFH) | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. |
|
|
|
| Secondary | Number of Subjects With Stroke | Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma). | Evaluable population | Posted | Number | participants | End of hospitalization, Day 30 |
|
|
|
|
| Secondary | Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization | Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization. | Evaluable population | Posted | Number | participants | End of hospitalization, Day 30 |
|
|
|
|
| Secondary | Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days | Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. | Evaluable population | Posted | Number | participants | End of hospitalization, Day 30 |
|
|
|
|
| Secondary | Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization | Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically. | Evaluable population | Posted | Number | participants | End of hospitalization, Day 30 |
|
|
|
| Secondary | Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria | Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%. | Evaluable population | Posted | Number | participants | End of hospitalization, Day 30 |
|
|
|
| 4 |
| 88 |
| 58 |
| 88 |
| EG001 | Arm B: Unfractioned Heparin (UFH) | Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed. | 13 | 83 | 59 | 83 |
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac asthma | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pseudophakia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Retinopathy hypertensive | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Facial pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Puncture site reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| ECG signs of myocardial ischaemia | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Electrocardiogram ST segment depression | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Venous pressure jugular increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Choking sensation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ischaemia | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |