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 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
NCT ID:
NCT00392834
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00392834
Study Brief:
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Regimen A (R-CODOX-M Chemotherapy) | Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover. | None | None | 0 | 2 | 0 | 2 | View |
| Regimen B (Rituximab and IVAC Chemotherapy) | Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy. | None | None | 23 | 32 | 22 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | None | Blood and lymphatic system disorders | MedDRA 10 | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Acute coronary syndrome | None | Cardiac disorders | MedDRA (10.0) | View |
| Left ventricular systolic dysfunction | None | Cardiac disorders | MedDRA (10.0) | View |
| supraventricular tachycardia | None | Cardiac disorders | MedDRA (10.0) | View |
| Extraocular muscle paresis | None | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Death NOS | None | General disorders | MedDRA (10.0) | View |
| Fever | None | General disorders | MedDRA (10.0) | View |
| Catheter related infection | None | Infections and infestations | MedDRA (10.0) | View |
| Infections and infestations, other | None | Infections and infestations | MedDRA (10.0) | View |
| Lung infection | None | Infections and infestations | MedDRA (10.0) | View |
| Sepsis | None | Infections and infestations | MedDRA (10.0) | View |
| Skin infection | None | Infections and infestations | MedDRA (10.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Vascular access complication | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Cardiac tropinin I increased | None | Investigations | MedDRA (10.0) | View |
| Creatinine increased | None | Investigations | MedDRA (10.0) | View |
| Lymphocyte count decreased | None | Investigations | MedDRA (10.0) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (10.0) | View |
| Platelet count decreased | None | Investigations | MedDRA (10.0) | View |
| White blood cell decreased | None | Investigations | MedDRA (10.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Tumor lysis syndrome | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Myelodysplastic syndrome | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Encephalopathy | None | Nervous system disorders | MedDRA (10.0) | View |
| Ischemia cerebrovascular | None | Nervous system disorders | MedDRA (10.0) | View |
| Transient ischemia attach | None | Nervous system disorders | MedDRA (10.0) | View |
| Nystagmus | None | Nervous system disorders | MedDRA (10.0) | View |
| Oculomotor nerve disorder | None | Nervous system disorders | MedDRA (10.0) | View |
| Peripheral sensory neuropathy | None | Nervous system disorders | MedDRA (10.0) | View |
| Acute kidney injury | None | Renal and urinary disorders | MedDRA (10.0) | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Hypotension | None | Vascular disorders | MedDRA (10.0) | View |
| Thromboembolic event | None | Vascular disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | None | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Diarrhea | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Oral mucositis | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Pain | None | General disorders | MedDRA (10.0) | View |
| Urinary tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Activated partial thromboplastin time prolonged | None | Investigations | MedDRA (10.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Blood bilirubin increased | None | Investigations | MedDRA (10.0) | View |
| Lymphocyte count decreased | None | Investigations | MedDRA (10.0) | View |
| Neutrophil count decreased | None | Investigations | MedDRA (10.0) | View |
| Platelet count decreased | None | Investigations | MedDRA (10.0) | View |
| Weight loss | None | Investigations | MedDRA (10.0) | View |
| White blood cell count decreased | None | Investigations | MedDRA (10.0) | View |
| Hypercalcemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypocalcemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypoglycemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypokalemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hyponatremia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Hypophosphatemia | None | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Headache | None | Nervous system disorders | MedDRA (10.0) | View |
| Confusion | None | Psychiatric disorders | MedDRA (10.0) | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |