Trial Outcomes & Findings for Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI) (NCT NCT00910299)
NCT ID: NCT00910299
Last Updated: 2012-06-08
Results Overview
The endpoint in this measure is a combination of cardiovascular death or MI.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
423 participants
Primary outcome timeframe
Baseline through 6 months
Results posted on
2012-06-08
Participant Flow
Participant milestones
| Measure |
Prasugrel
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
211
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
210
|
210
|
|
Overall Study
COMPLETED
|
136
|
137
|
|
Overall Study
NOT COMPLETED
|
76
|
74
|
Reasons for withdrawal
| Measure |
Prasugrel
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
13
|
|
Overall Study
Sponsor Decision
|
58
|
60
|
|
Overall Study
Didn't receive any study drug
|
2
|
1
|
Baseline Characteristics
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
Baseline characteristics by cohort
| Measure |
Prasugrel
n=212 Participants
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
n=211 Participants
75 mg oral daily maintenance dose up to 6 months.
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
65.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
211 participants
n=5 Participants
|
207 participants
n=7 Participants
|
418 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
200 participants
n=5 Participants
|
198 participants
n=7 Participants
|
398 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 6 monthsPopulation: Participants who were randomized.
The endpoint in this measure is a combination of cardiovascular death or MI.
Outcome measures
| Measure |
Prasugrel
n=212 Participants
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
n=211 Participants
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 6 monthsPopulation: Participants who were randomized.
Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.
Outcome measures
| Measure |
Prasugrel
n=212 Participants
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
n=211 Participants
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Number of Participants With Stent Thrombosis (ST)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through 6 monthsPopulation: Participants who were randomized.
The endpoint in this measure is a combination of all-cause death or MI.
Outcome measures
| Measure |
Prasugrel
n=212 Participants
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
n=211 Participants
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)
|
0 participants
|
2 participants
|
Adverse Events
Prasugrel
Serious events: 40 serious events
Other events: 110 other events
Deaths: 0 deaths
Clopidogrel
Serious events: 38 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prasugrel
n=210 participants at risk
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
n=210 participants at risk
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
2.9%
6/210 • Number of events 6
|
0.95%
2/210 • Number of events 2
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Cardiac disorders
Cardiac failure
|
0.48%
1/210 • Number of events 1
|
0.95%
2/210 • Number of events 2
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Coronary artery stenosis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
General disorders
Catheter site haemorrhage
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
General disorders
Chest pain
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
General disorders
Non-cardiac chest pain
|
0.95%
2/210 • Number of events 2
|
2.4%
5/210 • Number of events 5
|
|
Infections and infestations
Arthritis infective
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Bronchitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Cellulitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 2
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Investigations
Troponin increased
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/210
|
0.48%
1/210 • Number of events 2
|
|
Psychiatric disorders
Panic attack
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Renal and urinary disorders
Renal impairment
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.48%
1/210 • Number of events 2
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Hypertension
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Hypertensive crisis
|
1.4%
3/210 • Number of events 3
|
0.95%
2/210 • Number of events 2
|
|
Vascular disorders
Intermittent claudication
|
0.48%
1/210 • Number of events 2
|
0.00%
0/210
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
Other adverse events
| Measure |
Prasugrel
n=210 participants at risk
One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
|
Clopidogrel
n=210 participants at risk
75 mg oral daily maintenance dose up to 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
2.9%
6/210 • Number of events 6
|
0.95%
2/210 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.95%
2/210 • Number of events 2
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.95%
2/210 • Number of events 2
|
1.4%
3/210 • Number of events 3
|
|
Cardiac disorders
Bradycardia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Cardiac disorders
Bundle branch block left
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.95%
2/210 • Number of events 2
|
0.00%
0/210
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/210 • Number of events 1
|
0.95%
2/210 • Number of events 2
|
|
Eye disorders
Conjunctival haemorrhage
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Eye disorders
Conjunctivitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Eye disorders
Glaucoma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Gastrointestinal disorders
Abdominal pain
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/210
|
0.48%
1/210 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
3/210 • Number of events 3
|
2.9%
6/210 • Number of events 6
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Gastrointestinal disorders
Gastritis
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Gingivitis
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Gastrointestinal disorders
Nausea
|
0.95%
2/210 • Number of events 2
|
1.4%
3/210 • Number of events 3
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
General disorders
Chest pain
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
General disorders
Fatigue
|
0.95%
2/210 • Number of events 2
|
0.48%
1/210 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
General disorders
Oedema due to cardiac disease
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
General disorders
Oedema peripheral
|
1.4%
3/210 • Number of events 3
|
0.95%
2/210 • Number of events 2
|
|
General disorders
Vessel puncture site haematoma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Immune system disorders
Seasonal allergy
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Acute tonsillitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Bronchitis
|
1.4%
3/210 • Number of events 4
|
0.95%
2/210 • Number of events 2
|
|
Infections and infestations
Cystitis
|
0.95%
2/210 • Number of events 2
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Diverticulitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Erysipelas
|
0.95%
2/210 • Number of events 2
|
0.00%
0/210
|
|
Infections and infestations
Furuncle
|
1.4%
3/210 • Number of events 3
|
0.00%
0/210
|
|
Infections and infestations
Gastrointestinal infection
|
0.48%
1/210 • Number of events 1
|
1.4%
3/210 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
15/210 • Number of events 18
|
3.8%
8/210 • Number of events 8
|
|
Infections and infestations
Onychomycosis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Oral herpes
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Otitis externa
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Infections and infestations
Urinary tract infection
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
7/210 • Number of events 7
|
0.95%
2/210 • Number of events 2
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Injury, poisoning and procedural complications
Joint capsule rupture
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.4%
3/210 • Number of events 3
|
0.00%
0/210
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.9%
4/210 • Number of events 4
|
1.9%
4/210 • Number of events 4
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.95%
2/210 • Number of events 2
|
0.00%
0/210
|
|
Investigations
Arteriogram coronary
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Investigations
Blood creatine increased
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
Investigations
Blood creatine phosphokinase mb increased
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.48%
1/210 • Number of events 1
|
1.4%
3/210 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.95%
2/210 • Number of events 2
|
0.00%
0/210
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemic syndrome
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
2/210 • Number of events 2
|
0.48%
1/210 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.95%
2/210 • Number of events 2
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Dizziness
|
0.48%
1/210 • Number of events 1
|
0.48%
1/210 • Number of events 1
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Headache
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Paraesthesia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Sciatica
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Nervous system disorders
Syncope
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Psychiatric disorders
Anxiety disorder
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Psychiatric disorders
Insomnia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Psychiatric disorders
Nightmare
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Psychiatric disorders
Panic attack
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Psychiatric disorders
Sleep disorder
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Renal and urinary disorders
Renal failure chronic
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/210 • Number of events 3
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
20/210 • Number of events 21
|
3.8%
8/210 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
3/210 • Number of events 3
|
1.4%
3/210 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
6/210 • Number of events 6
|
0.48%
1/210 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/210
|
0.95%
2/210 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
3/210 • Number of events 3
|
0.48%
1/210 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/210
|
1.4%
3/210 • Number of events 3
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Surgical and medical procedures
Nasal septal operation
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.95%
2/210 • Number of events 2
|
0.00%
0/210
|
|
Surgical and medical procedures
Renal revascularisation surgery
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Surgical and medical procedures
Smoking cessation therapy
|
0.00%
0/210
|
0.48%
1/210 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Haematoma
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Hot flush
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Hypertension
|
1.4%
3/210 • Number of events 3
|
0.95%
2/210 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Thrombophlebitis
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
|
Vascular disorders
Varicose vein
|
0.48%
1/210 • Number of events 1
|
0.00%
0/210
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60