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:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
NCT ID:
NCT03387020
Description:
Adverse events (AEs) were graded using CTCAE v5.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to Ribociclib or Everolimus and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. Two patients did not started phase I protocol defined therapy and were not counted as at risk.
Frequency Threshold:
5
Time Frame:
Up to 2 years after starting treatment
Study:
NCT03387020
Study Brief:
Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I, Dose Level 1 | Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day | 5 | None | 6 | 12 | 12 | 12 | View |
| Phase I, Dose Level 2 | Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day | 0 | None | 1 | 3 | 3 | 3 | View |
| Surgical | Patients who are undergoing surgery also received ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery. Eligible patients were subsequently treated on Phase 1, Dose Level 1. | 0 | None | 1 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Muscle weakness left-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Tumor hemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| DECREASED VISUAL FIELDS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Edema cerebral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Glossopharyngeal nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| MOTOR APRAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Electrocardiogram QT corrected interval prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| DISEASE PROGRESSION | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Ataxia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (5.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Irritability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (5.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| PEDIATRIC HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Corneal ulcer | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |