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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT02765256
Description: None
Frequency Threshold: 0
Time Frame: 105 days
Study: NCT02765256
Study Brief: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluconazole Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). 0 None 0 4 4 4 View
Placebo Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily 0 None 0 4 3 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Perianal irritation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Defecation urgency NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View