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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:31 AM
NCT ID: NCT00074802
Description: The pharmacotherapist used a checklist to inquire about the presence of 29 potential adverse effects at each visit and rated the severity of each on a scale from 0 to 3 (none, mild, moderate, or severe). Any event with a rating greater than 0 reported at any of the visits listed above is included here.
Frequency Threshold: 0
Time Frame: Adverse events (AEs) were assessed from the beginning of the open trial phase of the study and throughout the randomized phase in which patients received paroxetine with or without CBT. Data presented in the Serious Adverse Events (SAE) and AE tables refer to events occurring during the randomized phase (Weeks 12, 16, 20, 24, and 28).
Study: NCT00074802
Study Brief: Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
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 Continuation Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. 0 None 1 29 29 29 View
Paroxetine With CBT Augmentation Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions. 0 None 0 32 29 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Libido SYSTEMATIC_ASSESSMENT General disorders None View
Anorgasmia SYSTEMATIC_ASSESSMENT General disorders None View
Impaired Coordination SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations SYSTEMATIC_ASSESSMENT General disorders None View
Myalgia SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Photophobia SYSTEMATIC_ASSESSMENT General disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT General disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Blurry Vision SYSTEMATIC_ASSESSMENT General disorders None View
Parathesias SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nervousness SYSTEMATIC_ASSESSMENT General disorders None View
Tremor SYSTEMATIC_ASSESSMENT General disorders None View
Weight Gain SYSTEMATIC_ASSESSMENT General disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT General disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT General disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Rigidity SYSTEMATIC_ASSESSMENT General disorders None View
Somnolence SYSTEMATIC_ASSESSMENT General disorders None View