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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT00790868
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored and elicited by open questioning of the study clinician, assessing adverse events occurring over the last hour as well as during the week following the last dose of DCS. AEs and SAEs were informally assessed up to the 6-month follow-up.
Study: NCT00790868
Study Brief: Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic 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
Placebo Placebo-augmented CBT Placebo: 50mg 0 None 1 92 18 92 View
D-cycloserine DCS-augmented CBT D-cycloserine: 50mg 0 None 1 88 17 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Kidney Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal distress SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Sedation SYSTEMATIC_ASSESSMENT General disorders None View
Jitteriness/tremor SYSTEMATIC_ASSESSMENT General disorders None View
Agitation/restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness/lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety/panic SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Impaired concentration SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paresthesias SYSTEMATIC_ASSESSMENT General disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Derealization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Menstrual irregularity SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View