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 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
NCT ID:
NCT04765202
Description:
Safety population included all participants who signed the informed consent form (ICF) and were treated with the investigational treatment.
Frequency Threshold:
5
Time Frame:
Up to 13 months
Study:
NCT04765202
Study Brief:
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 Group 1: All Participants | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at 1 treatment site compared to SOMA Tx on other treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1. | 0 | None | 1 | 7 | 7 | 7 | View |
| Cohort 1 Group 1: AG Tx Sites | Participants who received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. | 0 | None | 0 | 7 | 3 | 7 | View |
| Cohort 1 Group 1: SOMA Tx Sites | Participants who received SOMA Tx at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1. | 0 | None | 0 | 7 | 1 | 7 | View |
| Cohort 1 Group 2: All Participants | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at treatment site compared to SOMA Tx on other treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, applied to wounds of 100 to 400 cm\^2 in area on Day 1. | 0 | None | 1 | 6 | 6 | 6 | View |
| Cohort 1 Group 2: AG Tx Sites | Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1. | 0 | None | 0 | 6 | 3 | 6 | View |
| Cohort 1 Group 2: SOMA Tx Sites | Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1. | 0 | None | 0 | 6 | 3 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Homicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pilonidal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Vascular device infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Corneal abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Exposure to communicable disease | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Gun shot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Skin graft failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Excessive granulation tissue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Hypertrophic scar | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Staphylococcal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Blood pressure diastolic abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |