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: 2025-12-24 @ 6:36 PM
Ignite Modification Date: 2025-12-25 @ 4:06 PM
NCT ID: NCT03621657
Description: Insufficient participant population, low enrollment
Frequency Threshold: 1
Time Frame: 6 months
Study: NCT03621657
Study Brief: The GRAFT Study: Gut RecolonizAtion by Fecal 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
Single Dose FMT Capsule DE FMT Capsule DE by mouth, 30 capsules in a single one-time dose 48-72 post-antibiotic course. Single Dose FMT Capsule DE: 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment. 0 None 0 1 1 1 View
Low Dose FMT Capsule DE FMT Capsule double-encapsulated (DE) by mouth, 5 capsules once daily with antibiotic, followed by 5 capsules daily for 7 days post-antibiotic Low Dose FMT Capsule DE: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course. 0 None 0 0 0 0 View
Placebo Oral Capsule Oral placebo capsules manufactured to mimic study capsule, 5 capsules daily with antibiotic course, followed by 5 capsules for 7 days post-antibiotic Placebo oral capsule: Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View