Adverse Events Module

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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 @ 12:08 AM
Ignite Modification Date: 2025-12-25 @ 10:08 PM
NCT ID: NCT03880058
Description: No difference in definition Systematic Assessment: Subjects were questioned for the occurrence of any new or worsening signs or symptoms at each visit. Safety laboratory tests were conducted at select study visits. Clinically significant adverse events were reported.
Frequency Threshold: 0
Time Frame: Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit).
Study: NCT03880058
Study Brief: Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SLI-F06 Drug Product under investigation SLI-F06: Active treatment 0 None 3 22 14 22 View
Formulation Buffer Placebo Formulation buffer: Placebo treatment 0 None 3 22 14 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 20.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seroma drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Skin necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Aortic arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dermoid cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Allergy to surgical sutures SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Drain site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Incision site hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Impaired healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View