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 |
|---|---|---|---|---|---|---|---|---|
| Treatment (Chemotherapy, Biological Therapy) | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies | None | None | 0 | 20 | 18 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphocyte count decreased | None | Investigations | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Agitation | None | Psychiatric disorders | None | View |
| Alanine aminotransferase increased | None | Investigations | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Ataxia | None | Nervous system disorders | None | View |
| Blood and lymphatic system disorders - Other | None | Blood and lymphatic system disorders | None | View |
| Cardiac disorders - Other | None | Cardiac disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | None | View |
| Hyponatremia | None | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | None | View |
| Infections and infestations - Other | None | Infections and infestations | None | View |
| Intracranial hemorrhage | None | Nervous system disorders | None | View |
| Nail loss | None | Skin and subcutaneous tissue disorders | None | View |
| Nervous system disorders - Other | None | Nervous system disorders | None | View |
| Oral hemorrhage | None | Gastrointestinal disorders | None | View |
| Platelet count decreased | None | Investigations | None | View |
| White blood cell decreased | None | Investigations | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Bladder infection | None | Infections and infestations | None | View |
| Confusion | None | Psychiatric disorders | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |