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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT01524133
Description: Individual descriptions were summarized to organ class
Frequency Threshold: 0
Time Frame: 52 weeks (24 Weeks of Treatment Phase and 28 weeks of follow-up)
Study: NCT01524133
Study Brief: PROlonGed ExpoSure Sertraline
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sertraline + Enhanced Medication Management (SERT/EMM) 24 weeks of sertraline + enhanced medication management Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8. 0 None 0 71 69 71 View
Prolonged Exposure + Sertraline (PE/SERT) Up to 13 sessions of prolonged exposure therapy + 24 weeks of sertraline Sertraline: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8. Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure 0 None 5 69 61 69 View
Prolonged Exposure + Placebo (PE/PLB) Up to 13 sessions of prolonged exposure therapy + 24 weeks of placebo Prolonged Exposure Therapy: up to 13 sessions of prolonged exposure 0 None 3 67 46 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dermatological SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematological SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Muskuloskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View