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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT02813694
Description: Adverse events are reported for randomized subjects who received at least one dose of study drug (Safety Population). Treatment-emergent adverse events, defined as events occurring after the first dose of study drug, are reported. Adverse events were recorded whether or not they were considered to be study drug related.
Frequency Threshold: 2
Time Frame: Adverse events were recorded from the time of informed consent through the completion of the Test-of-Cure (TOC) Visit (i.e., 5-10 days after the last dose of study drug). Serious adverse events were recorded from the time of informed consent to the Late Follow-Up Visit (approximately 30 days after the first dose of study drug).
Study: NCT02813694
Study Brief: Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With 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
Moxifloxacin oral moxifloxacin, 400mg 3 None 18 368 12 368 View
Lefamulin oral lefamulin, 600mg 5 None 17 368 61 368 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Inguinal Hernia Strangulated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Lung Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumonia Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Tuberculous Pleurisy SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Nuclear Magnetic Resonance Imaging Brain Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Acute Myeloid Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Renal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Small Cell Lung Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Squamous Cell Carcinoma of Lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Cerebral Infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Embolic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View