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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT04160260
Description: Treatment-emergent adverse events (TEAEs), defined as any AEs that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article, were reported for the Safety Population (all enrolled participants who received at least one dose of oral omadacycline during the study).
Frequency Threshold: 5
Time Frame: From the first dose of study drug up to 37 days
Study: NCT04160260
Study Brief: Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
300 mg PO Omadacycline Participants received omadacycline 300 milligrams (mg) per oral (PO) twice daily (BID) on Day 1, followed by omadacycline 300 mg PO once daily (QD) from Day 2 through Day 10. 0 None 0 18 10 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 17.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 17.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 17.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 17.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 17.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 17.1 View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 17.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 17.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 17.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 17.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDra 17.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 17.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 17.1 View