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 @ 5:36 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
NCT ID:
NCT00653068
Description:
There were no patients enrolled in Stratum 2 or 4.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00653068
Study Brief:
Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Stratum I | Infants (\<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT | None | None | 7 | 57 | 43 | 57 | View |
| Stratum III | Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT. | None | None | 0 | 11 | 8 | 11 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Disseminated intravascular coagulation | None | Blood and lymphatic system disorders | None | View |
| Multi-organ failure | None | General disorders | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Upper respiratory infection | None | Infections and infestations | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | None | View |
| Central nervous system necrosis | None | Nervous system disorders | None | View |
| Intracranial hemorrhage | None | Nervous system disorders | None | View |
| Seizure | None | Nervous system disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Lymphocyte count decreased | None | Investigations | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Left ventricular systolic dysfunction | None | Cardiac disorders | None | View |
| Enterocolitis infectious | None | Infections and infestations | None | View |
| White blood cell decreased | None | Investigations | None | View |
| Acidosis | None | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Pulmonary edema | None | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | None | Infections and infestations | None | View |
| Injury, poisoning and procedural complications - Other, specify | None | Injury, poisoning and procedural complications | None | View |
| Intraoperative venous injury | None | Injury, poisoning and procedural complications | None | View |
| Vascular access complication | None | Injury, poisoning and procedural complications | None | View |
| Alanine aminotransferase increased | None | Investigations | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Investigations - Other, specify | None | Investigations | None | View |
| Lipase increased | None | Investigations | None | View |
| Lymphocyte count decreased | None | Investigations | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Weight loss | None | Investigations | None | View |
| White blood cell decreased | None | Investigations | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Hypernatremia | None | Metabolism and nutrition disorders | None | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | None | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hyponatremia | None | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | None | View |
| Hydrocephalus | None | Nervous system disorders | None | View |
| Recurrent laryngeal nerve palsy | None | Nervous system disorders | None | View |
| Seizure | None | Nervous system disorders | None | View |
| Acute kidney injury | None | Renal and urinary disorders | None | View |
| Hematuria | None | Renal and urinary disorders | None | View |
| Renal calculi | None | Renal and urinary disorders | None | View |
| Adult respiratory distress syndrome | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Apnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Aspiration | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Atelectasis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Laryngospasm | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Stridor | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Voice alteration | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Sinus tachycardia | None | Cardiac disorders | None | View |
| Hearing impaired | None | Ear and labyrinth disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Gastrointestinal disorders - Other, specify | None | Gastrointestinal disorders | None | View |
| Mucositis oral | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Death NOS | None | General disorders | None | View |
| Catheter related infection | None | Infections and infestations | None | View |
| Infections and infestations - Other, specify | None | Infections and infestations | None | View |
| Lung infection | None | Infections and infestations | None | View |