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 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
NCT ID:
NCT01371656
Description:
Routine reporting includes all toxicities reported via AdEERs and all grade 4 \& higher non-hematologic Adverse Events
Frequency Threshold:
0
Time Frame:
Up to 60 days after enrollment or receiving of levofloxacin
Study:
NCT01371656
Study Brief:
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
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 (Levofloxacin) | Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover. levofloxacin: Given PO or IV | 69 | None | 4 | 306 | 36 | 306 | View |
| Arm II (Standard of Care) | Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I. | 67 | None | 3 | 307 | 37 | 307 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE v4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Small intestine infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Adult respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Alkalosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Anaphylaxis | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE v4.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Asystole | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Bronchopulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Capillary leak syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Fibrinogen decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| GGT increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Hepatobiliary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypernatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Ileal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Infections and infestations - Other, specify | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Intracranial hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Left ventricular systolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v4.0 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v4.0 | View |
| Nervous system disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Portal hypertension | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Portal vein thrombosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE v4.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Renal and urinary disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v4.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Respiratory, thoracic and mediastinal disorders - Other, specify | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Reversible posterior leukoencephalopathy syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v4.0 | View |
| Stridor | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v4.0 | View |