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 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
NCT ID:
NCT01096368
Description:
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Frequency Threshold:
0
Time Frame:
Enrollment up to 10 years after enrollment.
Study:
NCT01096368
Study Brief:
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I: Observation | Patients with classic histology (WHO Grade II) supratentorial ependymoma who have undergone microscopic gross total resection (GTR1) or achieved CR either after first or second resection or after post-operative induction chemotherapy are assigned to observation. For patients without GTR1, induction chemotherapy is comprised of vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity. | 0 | None | 0 | 37 | 0 | 37 | View |
| Arm II: Randomized to Radiation With Maintenance Chemotherapy | Patients with supratentorial ependymoma (Grade II without GTR1 or Grade III) or any infratentorial ependymoma who have undergone gross or near total resection (GTR or NTR) or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks followed by maintenance chemotherapy. Maintenance chemotherapy comprised of vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients without GTR or NTR at enrollment require induction chemotherapy (see Arm I) and possibly second surgery before randomization. | 20 | None | 5 | 164 | 22 | 164 | View |
| Arm III: Randomized to Radiation Only | Patients with supratentorial ependymoma (Grade II without GTR1 or ST Grade III) or any infratentorial ependymoma (Grade II or III) who have undergone gross or near total resection or achieved CR either after first or second resection or after post-operative induction chemotherapy are randomized to undergo conformal radiotherapy over 6-7 weeks and then undergo observation. | 27 | None | 0 | 161 | 10 | 161 | View |
| Arm IV: Nonrandomly Assigned to Arm II Treatment | Patients with subtotal resection after induction chemotherapy (see Arm I) and second surgery are nonrandomly assigned to Arm II treatment. | 22 | None | 1 | 63 | 15 | 63 | View |
| Not Ependymoma or Withdrew Before Radiation | Patients with tumor other than ependymoma or withdrew before protocol-specified radiotherapy administered | 4 | None | 0 | 24 | 4 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Treatment related secondary malignancy | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Ear and labyrinth disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Central nervous system necrosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Edema cerebral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vagus nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hallucinations | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Stridor | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |