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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT02853435
Description: Safety population was used to assess non-serious AEs and SAEs.
Frequency Threshold: 5
Time Frame: Non-serious AEs and SAEs were collected from Day 1 until follow-up (Up to 14 days in Part 1a, 11 days in Part 1b and 2 and 14 days in Part 3).
Study: NCT02853435
Study Brief: To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gepotidacin 1500 mg - R Capsules Participants received gepotidacin 1500 mg (3 x 500) mg - R capsules orally in one of the 3 treatment periods for 3 days in Part 1a. 0 None 0 26 8 26 View
Gepotidacin RC 2250 mg Fed Participants received gepotidacin 1500 mg (2 x 750) RC tablets in the fed state orally in one of the 3 treatment periods for 3 days in Part 3. 0 None 0 10 1 10 View
Gepotidacin RC 3000 mg Fed Participants received gepotidacin 3000 mg (4 x 750) RC tablets in the fed state in one of the 3 treatment periods in Part 3. 0 None 0 9 6 9 View
Placebo Participants received matching placebo to active tablets in the fed state in one of the 3 treatment periods in Part 3. 0 None 0 2 0 2 View
Gepotidacin 1500 mg RC Tablets Participants received gepotidacin 1500 mg (2 x 750) RC tablets orally in one of the 3 treatment periods for 3 days in Part 1a. 0 None 0 26 5 26 View
Gepotidacin 1500 mg HSWG Tablets Participants received gepotidacin 1500 mg (2 x 750) HSWG tablets orally in one of the three treatment periods in Part 1a. 0 None 0 26 9 26 View
Gepotidacin RC 1500 mg Tablets Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2. 0 None 0 10 6 10 View
Gepotidacin RC 3000 mg Tablets Participants received a single dose gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in Part 2 Period 2. 0 None 0 10 9 10 View
Gepotidacin RC 1500 mg Fed Participants received gepotidacin 1500 mg (2 x 750) RC tablets in the fed state orally in one of the 3 treatment periods for 3 days in Part 3. 0 None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Muscle contractions involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Faeces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View