TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00225147

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: pneumonia - severe
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: vertigo - severe
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 62 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 62 at risk
Study: NCT00225212

Adverse event: Blood and lymphatic system disorders - Other, neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 35 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonitis, BCNU-related
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 35 at risk

Adverse event: Death NOS, pneumonitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, Community acquired pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 35 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood and lymphatic system disorders - Other, neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Blood and lymphatic system disorders - Other, Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 35 at risk
Study: NCT00225251

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: patient reported headache
Frequency: 4 affected / 11 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: patient reported dry mouth
Frequency: 3 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: patient reported dizziness
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: reported difficulty sleeping
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: reported difficulty sleeping
Frequency: 3 affected / 7 at risk
Study: NCT00225758

Adverse event: Grade 3 diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Grade 2 diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 27 at risk

Adverse event: Grade 3 cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Grade 3 hypokalemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Grade 2 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Grade 2 vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Grade 2 nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Grade 2 lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Grade 2 fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Grade 2 rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 27 at risk

Adverse event: Grade 2 weight loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Grade 2 skeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Grade 2 edema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk
Study: NCT00225784

Adverse event: CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal disorder - stent obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Stent obstruction is common in patients with pancreatic cancer.
Frequency: 8 affected / 33 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 33 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Gastritis/GI Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Notes: This was related to a traumatic event, not to treatment.
Frequency: 1 affected / 33 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 33 at risk

Adverse event: Pain - gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Of the 22 patients experiencing Grade 3 neutropenia, only one developed neutropenic fever requiring hospitalization. The other 21 were managed in an outpatient setting.
Frequency: 22 affected / 33 at risk

Adverse event: Anaphylaxtic reaction to erbitux
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 37 at risk
Study: NCT00226577

Adverse event: Alanine Aminotransferase (ALT) - Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \> 5.0 \<= 20.0
Frequency: 3 affected / 52 at risk

Adverse event: Aspartate Aminotransferase (AST) - Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \> 5.0 \<= 20.0
Frequency: 1 affected / 52 at risk

Adverse event: Bicarbonate, serum low - Grade 4
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \< 8.0
Frequency: 8 affected / 52 at risk

Adverse event: Dermatology/skin - Grade 3
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Severe
Frequency: 1 affected / 52 at risk

Adverse event: Fatigue - Grade 3
Serious: yes
Organ System: General disorders
Notes: Severe fatigue interfering with ADL
Frequency: 1 affected / 52 at risk

Adverse event: Hemoglobin - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: \>= 6.5 \< 8.
Frequency: 2 affected / 52 at risk

Adverse event: Hyperglycemia - Grade 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \> 250.0 \<= 500.0
Frequency: 7 affected / 52 at risk

Adverse event: Leukocytes - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: \>= 1.0 \< 2.
Frequency: 3 affected / 52 at risk

Adverse event: Lymphocytes - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: \>= 0.2 \< .5
Frequency: 2 affected / 52 at risk

Adverse event: Neutrophils - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: \>= 0.5 \< 1.
Frequency: 4 affected / 52 at risk

Adverse event: Thrombocytopenia - Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 52 at risk
Study: NCT00226590

Adverse event: Esophageal stricture requiring dilatation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Hydropneumo
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk
Study: NCT00227539

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

Adverse event: Drug Reaction
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk
Study: NCT00227760

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vascular disorder - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 44 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Infection and infestations - other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk
Study: NCT00228423

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 56 at risk

Adverse event: Minor bleeding
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 57 at risk

Adverse event: Hospitalization for Coronary Ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 57 at risk

Adverse event: Minor bleeding
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk
Study: NCT00228566

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 246 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 246 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 246 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 246 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 246 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 246 at risk

Adverse event: Nasal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 246 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 246 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 246 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 246 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 246 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 246 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 246 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 246 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 246 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 246 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 246 at risk
Study: NCT00228813

Adverse event: Recurrent Disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Multi-organ system failure
Serious: yes
Organ System: General disorders
Notes: Multi-organ system failure was related to severe graft-versus-host disease and resulted in death.
Frequency: 2 affected / 8 at risk
Study: NCT00229931

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient admitted to hospital for shortness of breath
Frequency: 1 affected / 6 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient admitted to hospital for kidney failure
Frequency: 1 affected / 6 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk
Study: NCT00230126

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 28 at risk

Adverse event: Nausea/vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: not severe
Frequency: 9 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 27 at risk

Adverse event: Nausea/vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: not severe
Frequency: 7 affected / 27 at risk
Study: NCT00230282

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: G3; hospitalization after 4th cycle. Resolved with empiric antibiotics.
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: G3; required transfusion. Pre-existing AIHA
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: G3 Required brief course of oxygen therapy
Frequency: 1 affected / 25 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: G3 Hospitalized. Received IV antibiotics with resolution.
Frequency: 1 affected / 25 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: G3. Pre-existing AIHA
Frequency: 1 affected / 25 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: G3
Frequency: 1 affected / 25 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: G3 Oral mucositis
Frequency: 1 affected / 25 at risk
Study: NCT00231062

Adverse event: bacterial sinusitis
Serious: no
Organ System: General disorders
Frequency: 9 affected / 109 at risk
Study: NCT00231283

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient (one year) follow-up or who had an event prior to the end of follow-up.
Frequency: 1 affected / 95 at risk

Adverse event: Myocardial Infarction (Q wave or Non-Q wave)
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 3 affected / 96 at risk

Adverse event: Emergent CABG
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 1 affected / 96 at risk

Adverse event: Arterial revascularisation
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 6 affected / 95 at risk

Adverse event: Target Vessel Revascularization not involving the Target Lesion
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 1 affected / 95 at risk

Adverse event: Arterial revascularisation
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 7 affected / 95 at risk

Adverse event: Target Vessel Failure
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 10 affected / 96 at risk

Adverse event: Major Vascular Complications
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 1 affected / 95 at risk

Adverse event: Ischemic Complications
Serious: no
Organ System: Vascular disorders
Notes: The number at risk is defined as the number of patients who had sufficient one year post-procedure follow-up or who had at least one event prior to the end of follow-up.
Frequency: 1 affected / 96 at risk
Study: NCT00231478

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Migraine
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 78 at risk

Adverse event: oxygen saturation reduced
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 78 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 78 at risk
Study: NCT00231842

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: low count of white blood cells.
Frequency: 13 affected / 27 at risk
Study: NCT00231894

Adverse event: high CPK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Increased in CPK which was not attributable to the study medication (pioglitazone or placebo), but to another medication that the patient was on (gemfibrozil) which the patient had been prescribed previously by this clinical physician..
Frequency: 1 affected / 31 at risk

Adverse event: glucose increase
Serious: no
Organ System: Endocrine disorders
Notes: One subject had very high glucose values (376 fasting; 530 hour one GTT). It was determined the patient was on a placebo. There was a gap in the patient's insulin coverage..
Frequency: 1 affected / 25 at risk

Adverse event: glucose increase
Serious: no
Organ System: Endocrine disorders
Notes: Patient had high glucose levels and was determined to be on placebo arm of study.
Frequency: 1 affected / 25 at risk