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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 - Dose Level 1 | Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle | None | None | 1 | 5 | 4 | 5 | View |
| Cohort 2 - Dose Level 0 | Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 75 mg/m\^2 PO days 1-5 28 day cycle | None | None | 1 | 6 | 1 | 6 | View |
| Cohort 3 - Dose Level 1 | Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle | None | None | 1 | 5 | 2 | 5 | View |
| Cohort 4 - Dose Level 2 | Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 175 mg/m\^2 PO days 1-5 28 day cycle | None | None | 4 | 5 | 3 | 5 | View |
| Cohort 5 - Dose Level 1 | Bevacizmuab 10 mg/kg IV days 1 and 15 Irinotecan 125 mg/m\^2 IV days 1 and 15 Temozolomide 125 mg/m\^2 PO days 1-5 28 day cycle | None | None | 1 | 5 | 3 | 5 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neurology, other - pneumocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Thrombus - embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| GI illness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Neurologic deficits | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Shunt malfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Dystonic reaction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (3.0) | View |
| Hemolytic anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutrophils | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Lymphocytes | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| ALT/AST | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Thrombus | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Syncope/Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |