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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
NCT ID:
NCT02828358
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:
Up to 5 years
Study:
NCT02828358
Study Brief:
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| KMT2A-Rearranged | INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction. | 17 | None | 34 | 56 | 36 | 56 | View |
| KMT2A-Germline | Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity. | 1 | None | 1 | 22 | 10 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Blood and lymphatic system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCv4 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| General disorders and administration site conditions - Other, specify | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCv4 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCv4 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCv4 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Typhlitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Rectal mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCv4 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv4 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCv4 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCv4 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCv4 | View |
| Gastrointestinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Skin and subcutaneous tissue disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Skin ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCv4 | View |
| Tumor lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCv4 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Vascular disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCv4 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCv4 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Soft tissue infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Anal mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCv4 | View |
| Small intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCv4 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCv4 | View |