Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
NCT ID:
NCT00267020
Description:
Study-specific clinical outcomes due to progressive disease were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
Frequency Threshold:
5
Time Frame:
Baseline through study completion (27.7 months)
Study:
NCT00267020
Study Brief:
Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enzastaurin+Gemcitabine | Enzastaurin: 1200 milligrams (mg) administered orally (as three 400-mg doses) after a meal on Day 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 2 to 28 in Cycle 1, then 500 mg orally, daily (as five 100-mg tablets) after lunch on Days 1 to 28 in Cycle 2 and later. Gemcitabine: 1000 milligrams/square meter (mg/m\^2) administered intravenously on Days 1, 8 and 15 of each 28-day cycle. | None | None | 49 | 82 | 80 | 82 | View |
| Gemcitabine | Gemcitabine: 1000 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each of each 28-day cycle. | None | None | 23 | 39 | 38 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oesophageal varices haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Thrombosis in device | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Bile duct obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Bile duct stenosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Jaundice cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Thrombotic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Hydropneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Internal fixation of fracture | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 16.0 | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 16.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Laboratory test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |