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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
NCT ID:
NCT02193958
Description:
Definitions do not differ from clinicaltrials.gov
Frequency Threshold:
5
Time Frame:
Each patient was followed from baseline through the treatment period (maximum treatment period up to 31 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Study:
NCT02193958
Study Brief:
Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase 1 Cohort 2: 100mg/m2 | FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 2 | None | 2 | 3 | 3 | 3 | View |
| Phase 1 Cohort 3: 200mg/m2 | FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 3 | None | 4 | 4 | 4 | 4 | View |
| Phase 1 Cohort 5: 400mg/m2 | FF-10501-01 tablets BID for 14 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 7 | None | 7 | 7 | 7 | 7 | View |
| Phase 1 Cohort 6: 500mg/m2 | FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 4 | None | 5 | 5 | 5 | 5 | View |
| Phase 1 Cohort 8: 400mg/m2 | FF-10501-01 tablets BID for 28 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 5 | None | 7 | 7 | 7 | 7 | View |
| Phase 2a Cohort 9: 400mg/m2 | FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 8 | None | 15 | 17 | 17 | 17 | View |
| Phase 1 Cohort 1: 50mg/m2 | FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 3 | None | 2 | 3 | 3 | 3 | View |
| Phase 1 Cohort 4: 300mg/m2 | FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 4 | None | 3 | 4 | 4 | 4 | View |
| Phase 1 Cohort 7: 400mg/m2 | FF-10501-01 tablets BID every 21 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision. | 2 | None | 4 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pericarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| hemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| histiocytosis hematophagic | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| hematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
| neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| enterocolitis infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
| tumor lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| upper gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| melena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| enterobacter bacteremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| ecthyma | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| periorbital cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| stenotrophomonas infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| escherichia bacteremia/sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.0) | View |
| acute febrile neutrophilic dermatosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.0) | View |
| hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.0) | View |
| enterococcla infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.0) | View |
| atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.0) | View |
| abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.0) | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| edema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.0) | View |
| cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.0) | View |
| fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.0) | View |
| alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.0) | View |
| decreased appetitie | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.0) | View |
| muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.0) | View |
| confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.0) | View |
| delirium | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.0) | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | View |
| hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.0) | View |