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 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
NCT ID:
NCT02261532
Description:
None
Frequency Threshold:
0
Time Frame:
15 weeks
Study:
NCT02261532
Study Brief:
A Phase I Study of TAS-102 in Solid Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TAS-102 | TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. | 0 | None | 4 | 15 | 14 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Fatigue | None | General disorders | MedDRA ver18.0 | View |
| Platelet count decreased | None | Investigations | MedDRA ver18.0 | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | MedDRA ver18.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA ver18.0 | View |
| Headache | None | Nervous system disorders | MedDRA ver18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Constipation | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Flatulence | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Gastric dilatation | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Large intestinal obstruction | None | Gastrointestinal disorders | MedDRA ver18.0 | View |
| Neutrophil count decreased | None | Investigations | MedDRA ver18.0 | View |
| White blood cell count decreased | None | Investigations | MedDRA ver18.0 | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA ver18.0 | View |
| Haemoglobin decreased | None | Investigations | MedDRA ver18.0 | View |
| Platelet count decreased | None | Investigations | MedDRA ver18.0 | View |
| Blood bilirubin increased | None | Investigations | MedDRA ver18.0 | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA ver18.0 | View |
| Protein urine present | None | Investigations | MedDRA ver18.0 | View |
| Urine bilirubin increased | None | Investigations | MedDRA ver18.0 | View |
| Fatigue | None | General disorders | MedDRA ver18.0 | View |
| Oedema peripheral | None | General disorders | MedDRA ver18.0 | View |
| Pyrexia | None | General disorders | MedDRA ver18.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA ver18.0 | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA ver18.0 | View |
| Hypochloraemia | None | Metabolism and nutrition disorders | MedDRA ver18.0 | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA ver18.0 | View |
| Leukopenia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Neutropenia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Erythropenia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Lymphopenia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | MedDRA ver18.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA ver18.0 | View |
| Headache | None | Nervous system disorders | MedDRA ver18.0 | View |
| Hypoaesthesia | None | Nervous system disorders | MedDRA ver18.0 | View |
| Somnolence | None | Nervous system disorders | MedDRA ver18.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA ver18.0 | View |
| Tinnitus | None | Ear and labyrinth disorders | MedDRA ver18.0 | View |
| Dermatitis allergic | None | Skin and subcutaneous tissue disorders | MedDRA ver18.0 | View |
| Hyperhidrosis | None | Skin and subcutaneous tissue disorders | MedDRA ver18.0 | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | MedDRA ver18.0 | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA ver18.0 | View |
| Insomnia | None | Psychiatric disorders | MedDRA ver18.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA ver18.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA ver18.0 | View |