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 @ 4:57 AM
Ignite Modification Date: 2025-12-26 @ 3:57 AM
NCT ID: NCT02257918
Description: One enrolled participant was not subsequently treated and is not included in the number at risk.
Frequency Threshold: 5
Time Frame: All serious and non-serious adverse events were collected for 30 days after study product administration
Study: NCT02257918
Study Brief: Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD0914/ETX0914 2000mg Participants receive single oral dose of 2000 mg of AZD0914/ETX0914. None None 0 72 6 72 View
AZD0914/ETX0914 3000mg Participants receive single oral dose of 3000 mg of AZD0914/ETX0914. None None 1 67 12 67 View
Ceftriaxone 500mg Participants receive single intramuscular dose of 500 mg of ceftriaxone. None None 0 40 11 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gun shot wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Gonorrhea NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Injection Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Urethritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View