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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:56 PM
NCT ID: NCT01078168
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01078168
Study Brief: Alzheimer's Disease Acitretin Medication
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acitretin oral, 30 mg per day, day 1-28 Acitretin: 30mg per day from Day 1 to Day 28 None None 1 11 8 11 View
Placebo oral, day 1-28 Placebo: Placebo None None 0 10 5 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
persistent diarrhea None Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache None General disorders None View
migraine None General disorders None View
syncope None General disorders None View
light headedness None General disorders None View
derailment of blood glucose None General disorders None View
lowered glucose tolerance None General disorders None View
aggressiveness None General disorders None View
muscular pain None Musculoskeletal and connective tissue disorders None View
cataract surgery None Surgical and medical procedures None View
memory defect due to anaesthesia None Surgical and medical procedures None View
gastroenteritis None Gastrointestinal disorders None View
diarrhea None Gastrointestinal disorders None View
severe diarrhea None Gastrointestinal disorders None View
post-punctual syndrome None Surgical and medical procedures None View
exfoliation of callus None Skin and subcutaneous tissue disorders None View
dry lips None Skin and subcutaneous tissue disorders None View
dry eyes None Skin and subcutaneous tissue disorders None View
alopecia None Skin and subcutaneous tissue disorders None View
hypertensive crisis None Blood and lymphatic system disorders None View
gingivitis None Skin and subcutaneous tissue disorders None View
pruritus None Skin and subcutaneous tissue disorders None View
eczema None Skin and subcutaneous tissue disorders None View
dry skin None Skin and subcutaneous tissue disorders None View
backpain None General disorders None View
dry mouth None Skin and subcutaneous tissue disorders None View
infection due to insect sting None Skin and subcutaneous tissue disorders None View