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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT03460756
Description: None
Frequency Threshold: 1
Time Frame: Baseline up through Day 119
Study: NCT03460756
Study Brief: A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TID (2-week) Oral ganaxolone doses were titrated to a daily dose of 900 mg/day Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days 0 None 0 2 2 2 View
QHS (2-week) Oral ganaxolone doses were titrated to a daily dose of 675 mg/day QHS over 4 days, which was maintained until Day 10, followed by a taper over 4 days 0 None 0 14 5 14 View
QHS (4-week) Oral ganaxolone was dosed at a daily dose of 675 mg/day QHS for 28 days, followed by a taper over 4 days 0 None 0 25 16 25 View
1125 mg (4-week) Oral ganaxolone was dosed as 675 mg at approximately 7 PM or with supper (Q7PM) and QHS (for a total of 1,350 mg/day on the first 2 days), followed by a daily dose of 1,125 mg/day at Q7PM for 26 days and a taper over 4 days 0 None 1 43 32 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View