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 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
NCT ID:
NCT00642018
Description:
Deaths due to progressive disease are not considered adverse events and are reported in the Other Pre-Specified outcome measure for those who died during the 30-day post study treatment follow-up period.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00642018
Study Brief:
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate 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 |
|---|---|---|---|---|---|---|---|---|
| LY2181308 + Docetaxel | LY2181308 loading dose of 750 mg intravenously on Days 1-3, followed by a maintenance dose of 750 mg on Days 8 and 15 during first 21-day cycle. LY2181308 750 mg intravenously on Days 1, 8 and 15 in combination with docetaxel 75 mg/m² on Day 1 of every 21-day cycle from Cycle 2 and beyond. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. | None | None | 47 | 98 | 94 | 98 | View |
| Docetaxel | Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy. | None | None | 11 | 51 | 50 | 51 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Spinal column stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Cranial nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 14.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 14.1 | View |
| Urethral obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 14.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Respiratory acidosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 14.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 14.1 | View |
| Intussusception | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
| Deafness unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 14.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Diverticular perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Cystitis haemorrhagic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 14.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 14.1 | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 14.1 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | 14.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 14.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 14.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 14.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 14.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 14.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 14.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 14.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 14.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 14.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 14.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 14.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 14.1 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 14.1 | View |
| Onycholysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 14.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 14.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | 14.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | 14.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 14.1 | View |