Trial Outcomes & Findings for Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome (NCT NCT00435487)
NCT ID: NCT00435487
Last Updated: 2011-10-17
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
173 participants
Primary outcome timeframe
Baseline to Day 30
Results posted on
2011-10-17
Participant Flow
Subjects participated in the study between 22 June 2007 and 30 December 2008.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
86
|
|
Overall Study
TREATED
|
88
|
83
|
|
Overall Study
COMPLETED
|
76
|
71
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Other
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Withdrawal by Subject Prior to Treatment
|
0
|
2
|
|
Overall Study
Received Drug in Other Treatment Group
|
0
|
1
|
Baseline Characteristics
Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Arm A: Dalteparin
n=88 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=83 Participants
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.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 - 44 years
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Age, Customized
45 - 64 years
|
36 participants
n=5 Participants
|
40 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
46 participants
n=5 Participants
|
38 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 30Population: Evaluable population: all subjects who took study medication for at least 48 hours from baseline and had complete information on the endpoint.
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.
Outcome measures
| Measure |
Arm A: Dalteparin
n=79 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=78 Participants
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.
|
|---|---|---|
|
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
Death
|
2 participants
|
4 participants
|
|
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
Non-fatal Myocardial Infarction
|
2 participants
|
1 participants
|
|
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
Death or Non-fatal Myocardial Infarction
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: End of hospitalization, Day 30Population: Evaluable population
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).
Outcome measures
| Measure |
Arm A: Dalteparin
n=79 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=78 Participants
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.
|
|---|---|---|
|
Number of Subjects With Stroke
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End of hospitalization, Day 30Population: Evaluable population
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.
Outcome measures
| Measure |
Arm A: Dalteparin
n=79 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=78 Participants
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.
|
|---|---|---|
|
Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: End of hospitalization, Day 30Population: Evaluable population
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.
Outcome measures
| Measure |
Arm A: Dalteparin
n=79 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=78 Participants
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.
|
|---|---|---|
|
Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: End of hospitalization, Day 30Population: Evaluable population
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.
Outcome measures
| Measure |
Arm A: Dalteparin
n=79 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=78 Participants
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.
|
|---|---|---|
|
Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: End of hospitalization, Day 30Population: Evaluable population
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%.
Outcome measures
| Measure |
Arm A: Dalteparin
n=79 Participants
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.
|
Arm B: Unfractioned Heparin (UFH)
n=78 Participants
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.
|
|---|---|---|
|
Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria
|
0 participants
|
0 participants
|
Adverse Events
Arm A: Dalteparin
Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths
Arm B: Unfractioned Heparin (UFH)
Serious events: 13 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Dalteparin
n=88 participants at risk
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.
|
Arm B: Unfractioned Heparin (UFH)
n=83 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/88
|
2.4%
2/83
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Cardiac arrest
|
2.3%
2/88
|
1.2%
1/83
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Cardiogenic shock
|
1.1%
1/88
|
1.2%
1/83
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
1/88
|
0.00%
0/83
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/88
|
1.2%
1/83
|
|
General disorders
Chest pain
|
0.00%
0/88
|
2.4%
2/83
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/88
|
1.2%
1/83
|
|
Nervous system disorders
Hemiparesis
|
1.1%
1/88
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/88
|
1.2%
1/83
|
Other adverse events
| Measure |
Arm A: Dalteparin
n=88 participants at risk
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.
|
Arm B: Unfractioned Heparin (UFH)
n=83 participants at risk
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.
|
|---|---|---|
|
Investigations
Blood creatinine increased
|
2.3%
2/88
|
1.2%
1/83
|
|
Investigations
Blood pressure increased
|
1.1%
1/88
|
0.00%
0/83
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/88
|
2.4%
2/83
|
|
Investigations
Electrocardiogram ST segment depression
|
1.1%
1/88
|
0.00%
0/83
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
4/88
|
6.0%
5/83
|
|
Cardiac disorders
Angina pectoris
|
4.5%
4/88
|
1.2%
1/83
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/88
|
0.00%
0/83
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/88
|
3.6%
3/83
|
|
Cardiac disorders
Palpitations
|
0.00%
0/88
|
1.2%
1/83
|
|
Cardiac disorders
Tachycardia
|
2.3%
2/88
|
1.2%
1/83
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
1/88
|
1.2%
1/83
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
1/88
|
0.00%
0/83
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/88
|
0.00%
0/83
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
1/88
|
0.00%
0/83
|
|
Eye disorders
Cataract
|
1.1%
1/88
|
1.2%
1/83
|
|
Eye disorders
Eye pain
|
0.00%
0/88
|
1.2%
1/83
|
|
Eye disorders
Pseudophakia
|
0.00%
0/88
|
1.2%
1/83
|
|
Eye disorders
Retinopathy hypertensive
|
1.1%
1/88
|
0.00%
0/83
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/88
|
1.2%
1/83
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/88
|
1.2%
1/83
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/88
|
1.2%
1/83
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/88
|
3.6%
3/83
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/88
|
0.00%
0/83
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/88
|
1.2%
1/83
|
|
Gastrointestinal disorders
Constipation
|
6.8%
6/88
|
10.8%
9/83
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
2/88
|
4.8%
4/83
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/88
|
2.4%
2/83
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/88
|
1.2%
1/83
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/88
|
0.00%
0/83
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/88
|
1.2%
1/83
|
|
Gastrointestinal disorders
Haematemesis
|
1.1%
1/88
|
0.00%
0/83
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.1%
1/88
|
0.00%
0/83
|
|
Gastrointestinal disorders
Nausea
|
3.4%
3/88
|
7.2%
6/83
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/88
|
0.00%
0/83
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
4/88
|
4.8%
4/83
|
|
General disorders
Asthenia
|
1.1%
1/88
|
2.4%
2/83
|
|
General disorders
Chest pain
|
10.2%
9/88
|
7.2%
6/83
|
|
General disorders
Chills
|
1.1%
1/88
|
1.2%
1/83
|
|
General disorders
Facial pain
|
0.00%
0/88
|
1.2%
1/83
|
|
General disorders
Oedema
|
1.1%
1/88
|
0.00%
0/83
|
|
General disorders
Oedema peripheral
|
0.00%
0/88
|
4.8%
4/83
|
|
General disorders
Pain
|
3.4%
3/88
|
0.00%
0/83
|
|
General disorders
Puncture site reaction
|
0.00%
0/88
|
1.2%
1/83
|
|
General disorders
Pyrexia
|
14.8%
13/88
|
10.8%
9/83
|
|
Infections and infestations
Pneumonia
|
1.1%
1/88
|
0.00%
0/83
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/88
|
1.2%
1/83
|
|
Infections and infestations
Urinary tract infection
|
2.3%
2/88
|
3.6%
3/83
|
|
Investigations
International normalised ratio increased
|
0.00%
0/88
|
1.2%
1/83
|
|
Investigations
Platelet count decreased
|
1.1%
1/88
|
0.00%
0/83
|
|
Investigations
Venous pressure jugular increased
|
2.3%
2/88
|
2.4%
2/83
|
|
Investigations
White blood cell count increased
|
2.3%
2/88
|
0.00%
0/83
|
|
Metabolism and nutrition disorders
Acidosis
|
2.3%
2/88
|
1.2%
1/83
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/88
|
2.4%
2/83
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.3%
2/88
|
1.2%
1/83
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
1/88
|
2.4%
2/83
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
2/88
|
6.0%
5/83
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
1.1%
1/88
|
0.00%
0/83
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
1/88
|
1.2%
1/83
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
1/88
|
1.2%
1/83
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/88
|
1.2%
1/83
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/88
|
1.2%
1/83
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/88
|
1.2%
1/83
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
3/88
|
3.6%
3/83
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/88
|
1.2%
1/83
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/88
|
1.2%
1/83
|
|
Nervous system disorders
Dizziness
|
3.4%
3/88
|
2.4%
2/83
|
|
Nervous system disorders
Headache
|
4.5%
4/88
|
12.0%
10/83
|
|
Nervous system disorders
Syncope
|
0.00%
0/88
|
1.2%
1/83
|
|
Psychiatric disorders
Abnormal behaviour
|
1.1%
1/88
|
0.00%
0/83
|
|
Psychiatric disorders
Anxiety
|
4.5%
4/88
|
4.8%
4/83
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/88
|
1.2%
1/83
|
|
Psychiatric disorders
Psychotic disorder
|
1.1%
1/88
|
0.00%
0/83
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/88
|
2.4%
2/83
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.1%
1/88
|
0.00%
0/83
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/88
|
1.2%
1/83
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/88
|
0.00%
0/83
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/88
|
1.2%
1/83
|
|
Renal and urinary disorders
Renal disorder
|
1.1%
1/88
|
0.00%
0/83
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
1/88
|
0.00%
0/83
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.1%
1/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
2.3%
2/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
6/88
|
9.6%
8/83
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.8%
6/88
|
4.8%
4/83
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/88
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/88
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/88
|
2.4%
2/83
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.1%
1/88
|
4.8%
4/83
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
2.3%
2/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
1/88
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
1.1%
1/88
|
0.00%
0/83
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/88
|
1.2%
1/83
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
1/88
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.1%
1/88
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/88
|
1.2%
1/83
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/88
|
1.2%
1/83
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/88
|
1.2%
1/83
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
1.1%
1/88
|
0.00%
0/83
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/88
|
1.2%
1/83
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/88
|
1.2%
1/83
|
|
Vascular disorders
Haematoma
|
1.1%
1/88
|
1.2%
1/83
|
|
Vascular disorders
Hypertension
|
1.1%
1/88
|
1.2%
1/83
|
|
Vascular disorders
Hypotension
|
0.00%
0/88
|
3.6%
3/83
|
|
Vascular disorders
Ischaemia
|
0.00%
0/88
|
2.4%
2/83
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/88
|
1.2%
1/83
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/88
|
1.2%
1/83
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER