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 @ 3:53 PM
Ignite Modification Date: 2025-12-25 @ 1:59 PM
NCT ID: NCT00913692
Description: None
Frequency Threshold: 0
Time Frame: From start of drug to 1 month after the last dose of drug. Serious adverse events (SAEs) and non-serious adverse events (AEs) were followed until resolution or until the AE/SAE has stabilized and no more follow-up is required.
Study: NCT00913692
Study Brief: A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Phase 1 2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 \& 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold. None None 0 2 2 2 View
Washout 2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 \& 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold. None None 0 1 1 1 View
Treatment Phase 2 2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 \& 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold. None None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Oral dysaesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood lactate dehydrogenase abnormal SYSTEMATIC_ASSESSMENT Investigations NCI CTCAE table View
Tension Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sleep Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhea None Respiratory, thoracic and mediastinal disorders MedDRA View
Edema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View