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 @ 4:13 AM
Ignite Modification Date: 2025-12-26 @ 3:12 AM
NCT ID: NCT01658020
Description: None
Frequency Threshold: 0
Time Frame: About 1.5 years
Study: NCT01658020
Study Brief: A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DW224 Zabofloxacin Tablet 400mg given by oral administration Moxifloxacin Tablet 400mg: multiple-dose None None 0 175 17 175 View
Avelox Moxifloxacin Tablet 400mg given by oral administration Zabofloxacin Tablet 400mg: multiple-dose None None 0 167 16 167 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Vimiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Sputum retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Red blood cell microcytes present SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (10.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (10.0) View