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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01076166
Description: The 6 serious adverse events that occurred in 2 participants and the one non-serious adverse event are summarized.
Frequency Threshold: 0
Time Frame: All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid.
Study: NCT01076166
Study Brief: Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Klacid Granules (Total) Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information. None None 2 337 1 337 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Drug ineffective NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (13.1) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (13.1) View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (13.1) View
Hypophagia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (13.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (13.1) View