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 @ 5:42 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
NCT ID:
NCT00867568
Description:
None
Frequency Threshold:
5
Time Frame:
New adverse events collected from first dose of study drug to 30 days past last dose of study drug. Related adverse events followed until resolution, approximately 1 year.
Study:
NCT00867568
Study Brief:
TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| TPI 287 | TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts. | None | None | 3 | 18 | 14 | 18 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Hemorrhagic Cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Progression of disease resulting in death | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distention | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| ALT increase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| AST Increase | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Drug Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| GGT Increase | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Rash- Lip sore | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Neuropathic pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Neuropathy sensory | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Peripheral neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Albumin Increase | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hemorrhagic cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| INR | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Liver dysfunction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| SIADH | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |