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 @ 7:09 PM
Ignite Modification Date: 2025-12-25 @ 4:43 PM
NCT ID: NCT01130103
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01130103
Study Brief: Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Paroxetine Paroxetine and Prolonged Exposure Therapy None None 0 19 6 19 View
Placebo Pill Placebo pill plus Prolonged Exposure Therapy None None 0 18 5 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View
tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
parasthesias SYSTEMATIC_ASSESSMENT Nervous system disorders None View
decrease libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
anorgasmia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
impaired coordination SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nervousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
weight gain SYSTEMATIC_ASSESSMENT General disorders None View
weight loss SYSTEMATIC_ASSESSMENT General disorders None View
skin problems SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
difficulty urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
rigidity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
somnolence SYSTEMATIC_ASSESSMENT General disorders None View