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:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
NCT ID:
NCT00143403
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00143403
Study Brief:
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal 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 |
|---|---|---|---|---|---|---|---|---|
| 5-FU/FA | simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) | None | None | 15 | 152 | 146 | 152 | View |
| Irinotecan + 5-FU/FA | irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months) | None | None | 32 | 154 | 150 | 154 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(v5.1) | View |
| Anaemia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(v5.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(v5.1) | View |
| Axillary vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(v5.1) | View |
| Cardiac disorder NOS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(v5.1) | View |
| Catheter related complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(v5.1) | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Cholecystitis acute NOS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA(v5.1) | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(v5.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(v5.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(v5.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(v5.1) | View |
| Device failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA(v5.1) | View |
| Diarrhoea NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Gait abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Hepatic disorder NOS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA(v5.1) | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Injection site thrombosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Intestinal obstruction NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Liver abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(v5.1) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(v5.1) | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(v5.1) | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | View |
| Phlebitis NOS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(v5.1) | View |
| Pneumothorax NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Rectovaginal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Renal impairment NOS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA(v5.1) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(v5.1) | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA(v5.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Tachycardia NOS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA(v5.1) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA(v5.1) | View |
| Vomiting NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain, NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | View |
| Anemia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(v5.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(v5.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA(v5.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA(v5.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA(v5.1) | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA(v5.1) | View |
| Leukopenia NOS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(v5.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(v5.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA(v5.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(v5.1) | View |
| Appetite decreased NOS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA(v5.1) | View |
| Cholinergic syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Diarrhea, NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Dyspnoea NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA(v5.1) | View |
| Mucosal inflammation NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA(v5.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | View |
| Pigmentation disorder NOS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA(v5.1) | View |
| Rhinitis NOS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA(v5.1) | View |
| Vomiting, NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA(v5.1) | View |