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 @ 10:06 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT01739335
Description: None
Frequency Threshold: 0
Time Frame: Participants were enrolled for 3 months. Adverse Events (AE) and Serious Adverse Events (SAE) information were collected from randomization to study medication/placebo until 12 week follow-up and/or participant termination (whichever occurred first). If a participant experienced more than 1 of a given AE, the participant was counted only once for that AE. If a participant experienced more than one AE in a system organ class (SOC), the participant was counted only once in that SOC.
Study: NCT01739335
Study Brief: Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mifepristone (600 mg/Day) 600 mg/day mifepristone for one week Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week 0 None 1 41 21 41 View
Sugar Pill Placebo (sugar pill) for one week Mifepristone (600 mg/day) or placebo (sugar pill): 600 mg/day mifepristone or placebo (sugar pill) for one week 0 None 0 40 15 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Social stay hospitalization NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Energy Increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Road Traffic Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Blood thyroid stimulating hormone increase NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Electrocardiogram Prolonged QT interval NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Glomerular Filtration Rate Decrease NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Platelet Count Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Urine analysis abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Exertional headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Anger NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Depressed Mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Contact Dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Miliaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Sympathectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 19.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View