Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
Two additional subjects experienced SAEs that were not listed under a treatment group due to data error: Injury, Poisoning and Procedural Complications system organ class (1 subject; drug exposure during preganancy), and Musculoskeletal and Connective System Disorders System Organ Class (1 subject; neuropathic arthropathy).
|
|
Arm/Group Title
|
Exubera®
|
Non-Exubera®
|
Arm/Group Description |
Exubera® plus usual diabetes care
|
Usual diabetes care
|
Arm/Group Description |
Exubera® plus usual diabetes care
|
Usual diabetes care
|
|
|
Exubera®
|
Non-Exubera®
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Exubera®
|
Non-Exubera®
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
124/987 (12.56%) |
109/989 (11.02%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
2/987 (0.20%) |
0/989 (0.00%) |
Iron deficiency anaemia |
1/987 (0.10%) |
1/989 (0.10%) |
Lymphatic obstruction |
0/987 (0.00%) |
1/989 (0.10%) |
Cardiac disorders |
|
|
Acute coronary syndrome |
1/987 (0.10%) |
0/989 (0.00%) |
Angina pectoris |
2/987 (0.20%) |
3/989 (0.30%) |
Angina unstable |
0/987 (0.00%) |
2/989 (0.20%) |
Aortic valve incompetence |
1/987 (0.10%) |
0/989 (0.00%) |
Arrhythmia |
2/987 (0.20%) |
1/989 (0.10%) |
Arteriosclerosis coronary artery |
1/987 (0.10%) |
0/989 (0.00%) |
Atrial fibrillation |
2/987 (0.20%) |
1/989 (0.10%) |
Atrial flutter |
1/987 (0.10%) |
0/989 (0.00%) |
Atrial tachycardia |
1/987 (0.10%) |
0/989 (0.00%) |
Cardiac arrest |
0/987 (0.00%) |
1/989 (0.10%) |
Cardiac failure |
0/987 (0.00%) |
1/989 (0.10%) |
Cardiac failure congestive |
3/987 (0.30%) |
1/989 (0.10%) |
Cardio-respiratory arrest |
1/987 (0.10%) |
0/989 (0.00%) |
Cardiomyopathy |
0/987 (0.00%) |
1/989 (0.10%) |
Congestive cardiomyopathy |
1/987 (0.10%) |
0/989 (0.00%) |
Coronary artery disease |
5/987 (0.51%) |
2/989 (0.20%) |
Coronary artery occlusion |
0/987 (0.00%) |
2/989 (0.20%) |
Coronary artery stenosis |
2/987 (0.20%) |
1/989 (0.10%) |
Hypertensive heart disease |
1/987 (0.10%) |
0/989 (0.00%) |
Ischaemic cardiomyopathy |
1/987 (0.10%) |
0/989 (0.00%) |
Myocardial infarction |
5/987 (0.51%) |
4/989 (0.40%) |
Myocardial ischaemia |
1/987 (0.10%) |
0/989 (0.00%) |
Paroxysmal arrhythmia |
1/987 (0.10%) |
0/989 (0.00%) |
Tricuspid valve incompetence |
1/987 (0.10%) |
0/989 (0.00%) |
Ventricular tachycardia |
1/987 (0.10%) |
1/989 (0.10%) |
Congenital, familial and genetic disorders |
|
|
Cerebral palsy |
1/987 (0.10%) |
0/989 (0.00%) |
Endocrine disorders |
|
|
Goitre |
1/987 (0.10%) |
0/989 (0.00%) |
Eye disorders |
|
|
Blindness |
0/987 (0.00%) |
1/989 (0.10%) |
Cataract |
1/987 (0.10%) |
1/989 (0.10%) |
Diabetic retinopathy |
1/987 (0.10%) |
0/989 (0.00%) |
Eye degenerative disorder |
0/987 (0.00%) |
1/989 (0.10%) |
Macular oedema |
0/987 (0.00%) |
1/989 (0.10%) |
Gastrointestinal disorders |
|
|
Abdominal hernia |
0/987 (0.00%) |
1/989 (0.10%) |
Abdominal pain |
0/987 (0.00%) |
1/989 (0.10%) |
Colitis ulcerative |
0/987 (0.00%) |
1/989 (0.10%) |
Duodenitis |
1/987 (0.10%) |
0/989 (0.00%) |
Gastric haemorrhage |
1/987 (0.10%) |
0/989 (0.00%) |
Gastritis |
0/987 (0.00%) |
2/989 (0.20%) |
Gastrointestinal haemorrhage |
2/987 (0.20%) |
1/989 (0.10%) |
Inguinal hernia |
2/987 (0.20%) |
1/989 (0.10%) |
Pancreatitis |
0/987 (0.00%) |
1/989 (0.10%) |
Pancreatitis acute |
0/987 (0.00%) |
1/989 (0.10%) |
Pancreatitis chronic |
1/987 (0.10%) |
0/989 (0.00%) |
Small intestinal obstruction |
1/987 (0.10%) |
0/989 (0.00%) |
Volvulus |
0/987 (0.00%) |
1/989 (0.10%) |
General disorders |
|
|
Cardiac death |
0/987 (0.00%) |
1/989 (0.10%) |
Chest discomfort |
1/987 (0.10%) |
1/989 (0.10%) |
Chest pain |
7/987 (0.71%) |
9/989 (0.91%) |
Death |
2/987 (0.20%) |
1/989 (0.10%) |
Discomfort |
1/987 (0.10%) |
0/989 (0.00%) |
Drug ineffective |
2/987 (0.20%) |
0/989 (0.00%) |
Inflammation |
1/987 (0.10%) |
0/989 (0.00%) |
Malaise |
1/987 (0.10%) |
0/989 (0.00%) |
Oedema peripheral |
1/987 (0.10%) |
0/989 (0.00%) |
Organ failure |
0/987 (0.00%) |
1/989 (0.10%) |
Sudden death |
1/987 (0.10%) |
1/989 (0.10%) |
Hepatobiliary disorders |
|
|
Biliary colic |
1/987 (0.10%) |
0/989 (0.00%) |
Cholecystitis acute |
0/987 (0.00%) |
1/989 (0.10%) |
Cholelithiasis |
0/987 (0.00%) |
2/989 (0.20%) |
Immune system disorders |
|
|
Drug hypersensitivity |
1/987 (0.10%) |
0/989 (0.00%) |
Infections and infestations |
|
|
Abscess |
0/987 (0.00%) |
1/989 (0.10%) |
Abscess neck |
1/987 (0.10%) |
0/989 (0.00%) |
Appendicitis |
0/987 (0.00%) |
1/989 (0.10%) |
Cellulitis |
2/987 (0.20%) |
2/989 (0.20%) |
Diverticulitis |
1/987 (0.10%) |
0/989 (0.00%) |
Empyema |
0/987 (0.00%) |
1/989 (0.10%) |
Erysipelas |
1/987 (0.10%) |
0/989 (0.00%) |
Gangrene |
0/987 (0.00%) |
1/989 (0.10%) |
Gastroenteritis |
0/987 (0.00%) |
1/989 (0.10%) |
Gastrointestinal infection |
1/987 (0.10%) |
0/989 (0.00%) |
Herpes zoster |
0/987 (0.00%) |
1/989 (0.10%) |
Infected skin ulcer |
0/987 (0.00%) |
1/989 (0.10%) |
Lobar pneumonia |
1/987 (0.10%) |
0/989 (0.00%) |
Lower respiratory tract infection |
0/987 (0.00%) |
1/989 (0.10%) |
Lymph node tuberculosis |
1/987 (0.10%) |
0/989 (0.00%) |
Pneumonia |
3/987 (0.30%) |
2/989 (0.20%) |
Pyelonephritis |
0/987 (0.00%) |
1/989 (0.10%) |
Scrotal abscess |
1/987 (0.10%) |
0/989 (0.00%) |
Sepsis |
1/987 (0.10%) |
1/989 (0.10%) |
Staphylococcal infection |
1/987 (0.10%) |
0/989 (0.00%) |
Subcutaneous abscess |
1/987 (0.10%) |
1/989 (0.10%) |
Tooth abscess |
0/987 (0.00%) |
1/989 (0.10%) |
Urinary tract infection |
0/987 (0.00%) |
1/989 (0.10%) |
Injury, poisoning and procedural complications |
|
|
Accident |
0/987 (0.00%) |
1/989 (0.10%) |
Acetabulum fracture |
1/987 (0.10%) |
0/989 (0.00%) |
Ankle fracture |
2/987 (0.20%) |
2/989 (0.20%) |
Compression fracture |
0/987 (0.00%) |
1/989 (0.10%) |
Device malfunction |
1/987 (0.10%) |
0/989 (0.00%) |
Device occlusion |
1/987 (0.10%) |
0/989 (0.00%) |
Drug exposure during pregnancy |
1/987 (0.10%) |
0/989 (0.00%) |
Fall |
3/987 (0.30%) |
2/989 (0.20%) |
Head injury |
1/987 (0.10%) |
1/989 (0.10%) |
Hip fracture |
0/987 (0.00%) |
1/989 (0.10%) |
Implantable defibrillator malfunction |
0/987 (0.00%) |
1/989 (0.10%) |
Lower limb fracture |
0/987 (0.00%) |
1/989 (0.10%) |
Meniscus lesion |
1/987 (0.10%) |
0/989 (0.00%) |
Multiple injuries |
1/987 (0.10%) |
0/989 (0.00%) |
Paternal drugs affecting foetus |
0/987 (0.00%) |
1/989 (0.10%) |
Post procedural haematoma |
1/987 (0.10%) |
0/989 (0.00%) |
Rib fracture |
1/987 (0.10%) |
1/989 (0.10%) |
Scapula fracture |
0/987 (0.00%) |
1/989 (0.10%) |
Subdural haematoma |
1/987 (0.10%) |
2/989 (0.20%) |
Tendon rupture |
2/987 (0.20%) |
0/989 (0.00%) |
Therapeutic agent toxicity |
1/987 (0.10%) |
0/989 (0.00%) |
Wound |
1/987 (0.10%) |
0/989 (0.00%) |
Investigations |
|
|
Anti-insulin antibody increased |
1/987 (0.10%) |
0/989 (0.00%) |
Blood glucose decreased |
1/987 (0.10%) |
0/989 (0.00%) |
Blood glucose increased |
3/987 (0.30%) |
0/989 (0.00%) |
Catheterisation cardiac |
0/987 (0.00%) |
1/989 (0.10%) |
Forced expiratory volume decreased |
1/987 (0.10%) |
0/989 (0.00%) |
Metabolism and nutrition disorders |
|
|
Dehydration |
0/987 (0.00%) |
1/989 (0.10%) |
Diabetes mellitus |
1/987 (0.10%) |
0/989 (0.00%) |
Diabetes mellitus inadequate control |
2/987 (0.20%) |
1/989 (0.10%) |
Diabetic complication |
0/987 (0.00%) |
1/989 (0.10%) |
Diabetic foot |
1/987 (0.10%) |
0/989 (0.00%) |
Diabetic ketoacidosis |
1/987 (0.10%) |
5/989 (0.51%) |
Hypercalcaemia |
0/987 (0.00%) |
1/989 (0.10%) |
Hyperglycaemia |
2/987 (0.20%) |
2/989 (0.20%) |
Hyperkalaemia |
0/987 (0.00%) |
1/989 (0.10%) |
Hypoglycaemia |
7/987 (0.71%) |
6/989 (0.61%) |
Ketoacidosis |
1/987 (0.10%) |
0/989 (0.00%) |
Obesity |
1/987 (0.10%) |
0/989 (0.00%) |
Type 1 diabetes mellitus |
0/987 (0.00%) |
1/989 (0.10%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
1/987 (0.10%) |
0/989 (0.00%) |
Arthropathy |
0/987 (0.00%) |
1/989 (0.10%) |
Back pain |
1/987 (0.10%) |
0/989 (0.00%) |
Intervertebral disc disorder |
0/987 (0.00%) |
1/989 (0.10%) |
Intervertebral disc protrusion |
4/987 (0.41%) |
0/989 (0.00%) |
Monarthritis |
1/987 (0.10%) |
0/989 (0.00%) |
Neuropathic arthropathy |
2/987 (0.20%) |
0/989 (0.00%) |
Osteoarthritis |
2/987 (0.20%) |
2/989 (0.20%) |
Osteonecrosis |
1/987 (0.10%) |
0/989 (0.00%) |
Rotator cuff syndrome |
0/987 (0.00%) |
2/989 (0.20%) |
Spinal column stenosis |
1/987 (0.10%) |
0/989 (0.00%) |
Spinal disorder |
1/987 (0.10%) |
0/989 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Acute myeloid leukaemia |
1/987 (0.10%) |
0/989 (0.00%) |
Adenocarcinoma pancreas |
0/987 (0.00%) |
1/989 (0.10%) |
B-cell lymphoma |
1/987 (0.10%) |
0/989 (0.00%) |
Basal cell carcinoma |
0/987 (0.00%) |
1/989 (0.10%) |
Breast cancer |
1/987 (0.10%) |
0/989 (0.00%) |
Colon cancer |
1/987 (0.10%) |
0/989 (0.00%) |
Gammopathy |
1/987 (0.10%) |
0/989 (0.00%) |
Glioblastoma |
1/987 (0.10%) |
0/989 (0.00%) |
Hepatic neoplasm malignant |
1/987 (0.10%) |
1/989 (0.10%) |
Leukaemia |
0/987 (0.00%) |
1/989 (0.10%) |
Lipoma |
0/987 (0.00%) |
1/989 (0.10%) |
Lung neoplasm malignant |
3/987 (0.30%) |
0/989 (0.00%) |
Lymphoma |
1/987 (0.10%) |
0/989 (0.00%) |
Metastases to liver |
1/987 (0.10%) |
0/989 (0.00%) |
Metastatic neoplasm |
1/987 (0.10%) |
0/989 (0.00%) |
Non-Hodgkin's lymphoma |
1/987 (0.10%) |
0/989 (0.00%) |
Pancreatic carcinoma |
1/987 (0.10%) |
1/989 (0.10%) |
Prostate cancer |
0/987 (0.00%) |
1/989 (0.10%) |
Renal cell carcinoma |
0/987 (0.00%) |
1/989 (0.10%) |
Renal neoplasm |
0/987 (0.00%) |
1/989 (0.10%) |
Squamous cell carcinoma |
1/987 (0.10%) |
1/989 (0.10%) |
Uterine leiomyoma |
0/987 (0.00%) |
2/989 (0.20%) |
Nervous system disorders |
|
|
Brain stem infarction |
1/987 (0.10%) |
0/989 (0.00%) |
Carotid artery stenosis |
1/987 (0.10%) |
1/989 (0.10%) |
Central nervous system lesion |
1/987 (0.10%) |
0/989 (0.00%) |
Cerebral infarction |
1/987 (0.10%) |
0/989 (0.00%) |
Cerebrovascular accident |
6/987 (0.61%) |
3/989 (0.30%) |
Convulsion |
0/987 (0.00%) |
4/989 (0.40%) |
Facial paresis |
1/987 (0.10%) |
0/989 (0.00%) |
Haemorrhage intracranial |
0/987 (0.00%) |
1/989 (0.10%) |
Paraesthesia |
2/987 (0.20%) |
0/989 (0.00%) |
Presyncope |
0/987 (0.00%) |
1/989 (0.10%) |
Sciatica |
0/987 (0.00%) |
1/989 (0.10%) |
Syncope |
2/987 (0.20%) |
4/989 (0.40%) |
Thalamic infarction |
0/987 (0.00%) |
1/989 (0.10%) |
Transient ischaemic attack |
2/987 (0.20%) |
1/989 (0.10%) |
Psychiatric disorders |
|
|
Depression |
1/987 (0.10%) |
0/989 (0.00%) |
Drug abuse |
1/987 (0.10%) |
0/989 (0.00%) |
Emotional disorder |
0/987 (0.00%) |
1/989 (0.10%) |
Intentional self-injury |
1/987 (0.10%) |
0/989 (0.00%) |
Mental status changes |
1/987 (0.10%) |
0/989 (0.00%) |
Suicide attempt |
1/987 (0.10%) |
0/989 (0.00%) |
Renal and urinary disorders |
|
|
Calculus ureteric |
1/987 (0.10%) |
0/989 (0.00%) |
Hydroureter |
0/987 (0.00%) |
1/989 (0.10%) |
Nephrolithiasis |
1/987 (0.10%) |
1/989 (0.10%) |
Renal failure |
1/987 (0.10%) |
2/989 (0.20%) |
Renal failure chronic |
2/987 (0.20%) |
0/989 (0.00%) |
Tubulointerstitial nephritis |
1/987 (0.10%) |
0/989 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Asthma |
0/987 (0.00%) |
1/989 (0.10%) |
Chronic obstructive pulmonary disease |
1/987 (0.10%) |
0/989 (0.00%) |
Dyspnoea |
5/987 (0.51%) |
1/989 (0.10%) |
Dyspnoea exertional |
1/987 (0.10%) |
0/989 (0.00%) |
Lung disorder |
0/987 (0.00%) |
1/989 (0.10%) |
Lung infiltration |
1/987 (0.10%) |
0/989 (0.00%) |
Pulmonary embolism |
0/987 (0.00%) |
2/989 (0.20%) |
Pulmonary mass |
1/987 (0.10%) |
0/989 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
Angioedema |
1/987 (0.10%) |
0/989 (0.00%) |
Blister |
0/987 (0.00%) |
1/989 (0.10%) |
Decubitus ulcer |
0/987 (0.00%) |
1/989 (0.10%) |
Dermal cyst |
1/987 (0.10%) |
0/989 (0.00%) |
Diabetic ulcer |
1/987 (0.10%) |
0/989 (0.00%) |
Pruritus |
1/987 (0.10%) |
0/989 (0.00%) |
Surgical and medical procedures |
|
|
Cardiac operation |
1/987 (0.10%) |
0/989 (0.00%) |
Coronary arterial stent insertion |
0/987 (0.00%) |
1/989 (0.10%) |
Coronary artery bypass |
0/987 (0.00%) |
1/989 (0.10%) |
Toe amputation |
1/987 (0.10%) |
0/989 (0.00%) |
Vascular disorders |
|
|
Accelerated hypertension |
0/987 (0.00%) |
1/989 (0.10%) |
Aortic stenosis |
1/987 (0.10%) |
0/989 (0.00%) |
Arterial occlusive disease |
1/987 (0.10%) |
1/989 (0.10%) |
Deep vein thrombosis |
0/987 (0.00%) |
1/989 (0.10%) |
Haematoma |
1/987 (0.10%) |
0/989 (0.00%) |
Hypertension |
1/987 (0.10%) |
0/989 (0.00%) |
Hypertensive crisis |
0/987 (0.00%) |
1/989 (0.10%) |
Hypotension |
0/987 (0.00%) |
1/989 (0.10%) |
Orthostatic hypotension |
0/987 (0.00%) |
1/989 (0.10%) |
Peripheral arterial occlusive disease |
1/987 (0.10%) |
0/989 (0.00%) |
Peripheral artery aneurysm |
0/987 (0.00%) |
1/989 (0.10%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 12.0
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Exubera®
|
Non-Exubera®
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
26/987 (2.63%) |
11/989 (1.11%) |
Cardiac disorders |
|
|
Angina pectoris |
1/987 (0.10%) |
0/989 (0.00%) |
Eye disorders |
|
|
Vision blurred |
1/987 (0.10%) |
0/989 (0.00%) |
Gastrointestinal disorders |
|
|
Gingival pain |
1/987 (0.10%) |
0/989 (0.00%) |
Nausea |
0/987 (0.00%) |
1/989 (0.10%) |
General disorders |
|
|
Adverse drug reaction |
1/987 (0.10%) |
0/989 (0.00%) |
Fatigue |
1/987 (0.10%) |
1/989 (0.10%) |
Influenza like illness |
1/987 (0.10%) |
0/989 (0.00%) |
Oedema peripheral |
1/987 (0.10%) |
0/989 (0.00%) |
Infections and infestations |
|
|
Bronchitis |
1/987 (0.10%) |
0/989 (0.00%) |
Cellulitis |
0/987 (0.00%) |
1/989 (0.10%) |
Gingival infection |
1/987 (0.10%) |
0/989 (0.00%) |
Herpes zoster |
1/987 (0.10%) |
0/989 (0.00%) |
Lobar pneumonia |
1/987 (0.10%) |
0/989 (0.00%) |
Nasopharyngitis |
0/987 (0.00%) |
1/989 (0.10%) |
Sinusitis |
1/987 (0.10%) |
0/989 (0.00%) |
Skin bacterial infection |
1/987 (0.10%) |
0/989 (0.00%) |
Staphylococcal infection |
1/987 (0.10%) |
0/989 (0.00%) |
Upper respiratory tract infection |
1/987 (0.10%) |
0/989 (0.00%) |
Viral pharyngitis |
1/987 (0.10%) |
0/989 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Tooth fracture |
1/987 (0.10%) |
0/989 (0.00%) |
Investigations |
|
|
Blood glucose increased |
3/987 (0.30%) |
0/989 (0.00%) |
Cardiac murmur |
1/987 (0.10%) |
0/989 (0.00%) |
Catheterisation cardiac |
0/987 (0.00%) |
1/989 (0.10%) |
Forced expiratory volume decreased |
0/987 (0.00%) |
2/989 (0.20%) |
Weight decreased |
1/987 (0.10%) |
0/989 (0.00%) |
Metabolism and nutrition disorders |
|
|
Hyperglycaemia |
1/987 (0.10%) |
1/989 (0.10%) |
Hypoglycaemia |
2/987 (0.20%) |
1/989 (0.10%) |
Musculoskeletal and connective tissue disorders |
|
|
Pain in extremity |
1/987 (0.10%) |
0/989 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Lung neoplasm |
0/987 (0.00%) |
1/989 (0.10%) |
Nervous system disorders |
|
|
Facial palsy |
1/987 (0.10%) |
0/989 (0.00%) |
Haemorrhage intracranial |
0/987 (0.00%) |
1/989 (0.10%) |
Headache |
1/987 (0.10%) |
0/989 (0.00%) |
Psychiatric disorders |
|
|
Insomnia |
1/987 (0.10%) |
0/989 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Asthma |
0/987 (0.00%) |
1/989 (0.10%) |
Cough |
6/987 (0.61%) |
0/989 (0.00%) |
Dry throat |
1/987 (0.10%) |
0/989 (0.00%) |
Dyspnoea |
3/987 (0.30%) |
0/989 (0.00%) |
Oropharyngeal pain |
1/987 (0.10%) |
0/989 (0.00%) |
Painful respiration |
1/987 (0.10%) |
0/989 (0.00%) |
Pulmonary congestion |
1/987 (0.10%) |
0/989 (0.00%) |
Wheezing |
1/987 (0.10%) |
0/989 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
Stasis dermatitis |
0/987 (0.00%) |
1/989 (0.10%) |
Surgical and medical procedures |
|
|
Stent placement |
1/987 (0.10%) |
0/989 (0.00%) |
Vascular disorders |
|
|
Temporal arteritis |
1/987 (0.10%) |
0/989 (0.00%) |
Vascular stenosis |
1/987 (0.10%) |
0/989 (0.00%) |
Indicates events were collected by systematic assessment
Term from vocabulary, MedDRA 12.0
|