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 @ 12:24 AM
Ignite Modification Date: 2025-12-25 @ 10:29 PM
NCT ID: NCT03633058
Description: None
Frequency Threshold: 4.3
Time Frame: 6 weeks
Study: NCT03633058
Study Brief: A Study to Evaluate Ketamine for the Treatment of Rett 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
0.75 mg/kg Ketamine AEs reported while on ketamine in the 0.75 mg/kg cohort 0 None 0 11 2 11 View
1.5 mg/kg Placebo AEs reported while on placebo in the 1.5 mg/kg cohort 0 None 0 12 3 12 View
0.75 mg/kg Placebo AEs reported while on placebo in the 0.75 mg/kg cohort 0 None 0 11 4 11 View
1.5 mg/kg Ketamine AEs reported while on ketamine in the 1.5 mg/kg cohort 0 None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Stoma site irritation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
drooling SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Tonic convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View