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 |
|---|---|---|---|---|---|---|---|---|
| A Cint | Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome. drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome. | None | None | 13 | 95 | 81 | 95 | View |
| B Ccont | Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome. capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome. | None | None | 4 | 97 | 51 | 97 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | None | Infections and infestations | None | View |
| Obstruction | None | Gastrointestinal disorders | None | View |
| Ventricular arrhythmia | None | Cardiac disorders | None | View |
| Mucositis/stomatitis | None | Gastrointestinal disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Blood and lymphatic system disorders | None | View |
| Infection with unknown ANC | None | Infections and infestations | None | View |
| Rash: hand-foot skin reaction | None | Skin and subcutaneous tissue disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash: hand-foot skin reaction | None | Skin and subcutaneous tissue disorders | None | View |
| Grade 3-4 Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Grade 3-4 Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Grade 3-4 Diarrhea | None | Gastrointestinal disorders | None | View |
| Mucositis/stomatitis (functional/symptomatic) | None | Gastrointestinal disorders | None | View |