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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT01053156
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01053156
Study Brief: Trial of Minocycline to Treat Children With Fragile X Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Minocycline Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \>45 kg receiving 100 mg once daily. None None 0 66 53 66 View
Placebo Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \>45 kg receiving 100 mg once daily. None None 1 66 53 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI Upset/ Vomiting/Loss of Appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin Rash/ Itching/ Swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever/Chills/URI/Sore Throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sunburn/Sun Sensitivity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased agitation, aggression, tantrums, uncooperative, irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Blue-grey/Grey hue to teeth or other tissues NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View