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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
NCT ID:
NCT00033293
Description:
The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00033293
Study Brief:
Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
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 (Chemotherapy, Immunoglobulin Therapy) | Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths. Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH). | None | None | 1 | 26 | 13 | 26 | View |
| Arm II (Chemotherapy, Observation) | Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months. Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I. | None | None | 1 | 27 | 18 | 27 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| 33300-Febrile neutropenia | None | Blood and lymphatic system disorders | CTCv4 | View |
| 74200-Sinus bradycardia | None | Cardiac disorders | CTCv4 | View |
| 22100-Colitis | None | Gastrointestinal disorders | CTCv4 | View |
| 25700-Diarrhea | None | Gastrointestinal disorders | CTCv4 | View |
| 31200-Esophagitis | None | Gastrointestinal disorders | CTCv4 | View |
| 36700-Gastrointestinal disorders - Other specify | None | Gastrointestinal disorders | CTCv4 | View |
| 46300-Intra-abdominal hemorrhage(targeted toxicity) | None | Gastrointestinal disorders | CTCv4 | View |
| 55600-Mucositis oral | None | Gastrointestinal disorders | CTCv4 | View |
| 57600-Nausea(targeted toxicity) | None | Gastrointestinal disorders | CTCv4 | View |
| 87900-Vomiting(targeted toxicity) | None | Gastrointestinal disorders | CTCv4 | View |
| 33900-Fever | None | General disorders | CTCv4 | View |
| 48700-Irritability | None | General disorders | CTCv4 | View |
| 16800-Bladder infection | None | Infections and infestations | CTCv4 | View |
| 20500-Catheter related infection | None | Infections and infestations | CTCv4 | View |
| 29500-Enterocolitis infectious | None | Infections and infestations | CTCv4 | View |
| 44800-Infections and infestations - Other specify | None | Infections and infestations | CTCv4 | View |
| 82300-Upper respiratory infection | None | Infections and infestations | CTCv4 | View |
| 83100-Urinary tract infection | None | Infections and infestations | CTCv4 | View |
| 34900-Fracture | None | Injury, poisoning and procedural complications | CTCv4 | View |
| 11600-Alanine aminotransferase increased | None | Investigations | CTCv4 | View |
| 15000-Aspartate aminotransferase increased | None | Investigations | CTCv4 | View |
| 53700-Lymphocyte count decreased | None | Investigations | CTCv4 | View |
| 58300-Neutrophil count decreased | None | Investigations | CTCv4 | View |
| 65800-Platelet count decreased | None | Investigations | CTCv4 | View |
| 88200-Weight gain | None | Investigations | CTCv4 | View |
| 88500-White blood cell decreased | None | Investigations | CTCv4 | View |
| 13500-Anorexia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 24700-Dehydration | None | Metabolism and nutrition disorders | CTCv4 | View |
| 41300-Hypercalcemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 41400-Hyperglycemia(targeted toxicity) | None | Metabolism and nutrition disorders | CTCv4 | View |
| 41600-Hyperkalemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 42600-Hypoalbuminemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 42700-Hypocalcemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 42900-Hypoglycemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 43100-Hypokalemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 43300-Hyponatremia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 43500-Hypophosphatemia | None | Metabolism and nutrition disorders | CTCv4 | View |
| 15300-Ataxia | None | Nervous system disorders | CTCv4 | View |
| 58700-Nystagmus | None | Nervous system disorders | CTCv4 | View |
| 69300-Pyramidal tract syndrome | None | Nervous system disorders | CTCv4 | View |
| 11400-Agitation | None | Psychiatric disorders | CTCv4 | View |
| 13700-Anxiety(targeted toxicity) | None | Psychiatric disorders | CTCv4 | View |
| 64400-Personality change | None | Psychiatric disorders | CTCv4 | View |
| 43900-Hypoxia | None | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| 41500-Hyperhidrosis | None | Skin and subcutaneous tissue disorders | CTCv4 | View |
| 69700-Rash maculo-papular(targeted toxicity) | None | Skin and subcutaneous tissue disorders | CTCv4 | View |
| 42100-Hypertension | None | Vascular disorders | CTCv4 | View |
| 24200-Cushingoid | None | Endocrine disorders | CTCv4 | View |
| 13200-Anemia | None | Blood and lymphatic system disorders | CTCv4 | View |
| 11200-Adrenal insufficiency | None | Endocrine disorders | CTCv4 | View |