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 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 1:13 PM
NCT ID:
NCT00469859
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00469859
Study Brief:
Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group 1 (Lestaurtinib Dose 50 mg/m2 | COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay. COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy. CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Continued (see detailed description) | None | None | 2 | 6 | 6 | 6 | View |
| Group 2 (Lestaurtinib: Dose 62.5 mg/m2 | COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay. COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy. CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Continued (see detailed description) | None | None | 6 | 8 | 8 | 8 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Acidosis | None | Metabolism and nutrition disorders | None | View |
| Activated partial thromboplastin time prolonged | None | Investigations | None | View |
| Alanine aminotransferase increased | None | Investigations | None | View |
| Alkalosis | None | Metabolism and nutrition disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Anxiety | None | Psychiatric disorders | None | View |
| Appendicitis perforated | None | Infections and infestations | None | View |
| Ascites | None | Gastrointestinal disorders | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Cardiac disorders - Other | None | Cardiac disorders | None | View |
| Chest wall pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Colitis | None | Gastrointestinal disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Disseminated intravascular coagulation | None | Blood and lymphatic system disorders | None | View |
| Dyspnea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Hyperglycemia | None | Metabolism and nutrition disorders | None | View |
| Hyperkalemia | None | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | None | View |
| Hypokalemia | None | Metabolism and nutrition disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Infections and infestations - Other | None | Infections and infestations | None | View |
| Intracranial hemorrhage | None | Nervous system disorders | None | View |
| Left ventricular systolic dysfunction | None | Cardiac disorders | None | View |
| Lymphocyte count decreased | None | Investigations | None | View |
| Mucositis oral | None | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Pericardial effusion | None | Cardiac disorders | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Pneumonitis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | None | View |
| Seizure | None | Nervous system disorders | None | View |
| Sinus tachycardia | None | Cardiac disorders | None | View |
| Typhlitis | None | Gastrointestinal disorders | None | View |
| Weight gain | None | Investigations | None | View |
| White blood cell decreased | None | Investigations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Adult respiratory distress syndrome | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Alanine aminotransferase increased | None | Investigations | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Depression | None | Psychiatric disorders | None | View |
| Erythema multiforme | None | Skin and subcutaneous tissue disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Fever | None | General disorders | None | View |
| Hemorrhoids | None | Gastrointestinal disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Hypertriglyceridemia | None | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | 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 |
| Hypotension | None | Vascular disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Infections and infestations - Other | None | Infections and infestations | None | View |
| Lipase increased | None | Investigations | None | View |
| Lymphocyte count decreased | None | Investigations | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | None | View |
| Rectal pain | None | Gastrointestinal disorders | None | View |
| Upper gastrointestinal hemorrhage | None | Gastrointestinal disorders | None | View |
| Uterine hemorrhage | None | Reproductive system and breast disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Weight loss | None | Investigations | None | View |
| White blood cell decreased | None | Investigations | None | View |