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 @ 11:46 PM
Ignite Modification Date:
2025-12-25 @ 9:39 PM
NCT ID:
NCT02406651
Description:
All SAEs and AEs were those assessed as possibly, probably, or definitely related to F-652 by the study Investigator at each site. Please note: 30 participants were dosed based on initial screening, so they were included in the safety population.
Frequency Threshold:
5
Time Frame:
AEs/SAEs were assessed from the time of screening until the end of Day 56 and all causality for mortality was assessed up to 1 year.
Study:
NCT02406651
Study Brief:
Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| F-652 and Systemic Coritcosteroids | Subjects were dosed once a week for four weeks with Recombinant Human Interleukin-22 IgG2-Fc (F-652). Dosing will be concurrent with systemic corticosteroids. Recombinant Human Interleukin-22 IgG2-Fc (F-652): IV infusion of reconstitution lyophilized F-652. Systemic Corticosteroids: Prednisone (or equivalent) was given at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) were given at a dose of 2 mg/kg/day and tapered as needed. | 4 | None | 10 | 30 | 26 | 30 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.1 | View |
| devise related infection | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 22.1 | View |
| klebsiella infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.1 | View |
| streptococcal pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.1 | View |
| sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 22.1 | View |
| muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | View |
| enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.1 | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.1 | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | View |
| dypsnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| hypokalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypomagnesemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypophosphatemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hyponatremia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypocalcemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hyperkalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypoglycemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypermagnesemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| white blood cell count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| international normalized ratio increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| peripheral edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.1 | View |
| dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.1 | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 22.1 | View |
| dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | View |
| pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | View |
| dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 22.1 | View |
| muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | View |
| hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 22.1 | View |
| platelet count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 22.1 | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 22.1 | View |