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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adjuvant Chemotherapy + Vidaza | Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC. Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC. Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC. Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles | None | None | 1 | 6 | 5 | 6 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alopecia | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Dermatology - Skin, other | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Edema - limbs | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hypomagnesemia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Neurology - other | None | Nervous system disorders | CTCAE (3.0) | View |
| Petechiae | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Taste alteration | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Abdominal Pain | None | General disorders | CTCAE (3.0) | View |
| Anorexia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Bone pain | None | General disorders | CTCAE (3.0) | View |
| Bronchitis | None | Infections and infestations | CTCAE (3.0) | View |
| Constipation | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Creatinine increased | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Dehydration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Edema - head and neck | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Fatigue | None | General disorders | CTCAE (3.0) | View |
| Hemolysis | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Joint pain | None | General disorders | CTCAE (3.0) | View |
| Large intestinal mucositis | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | CTCAE (3.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Thrombosis/thrombus/embolism | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Urine discoloration | None | Renal and urinary disorders | CTCAE (3.0) | View |
| Weight loss | None | General disorders | CTCAE (3.0) | View |