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: 2025-12-26 @ 5:22 PM
Ignite Modification Date: 2025-12-26 @ 5:22 PM
NCT ID: NCT02563106
Description: The "Total" reported in the "Other (Not Including Serious) Adverse Events (AEs) Section" for SYN-004 and Placebo indicate the total number of AEs. The number of subjects "Affected" by those AEs is 42 for SYN-004 and 46 for Placebo. The frequency threshold of 1% for non-serious adverse events is reported as the # of subjects w/ AEs (excluding Serious Adverse Events (SAEs)) in each group, based on # of subjects w/ AEs \>1% in the SYN-004 group \& the corresponding AE categories for Placebo group.
Frequency Threshold: 1
Time Frame: 6 weeks.
Study: NCT02563106
Study Brief: A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SYN-004 SYN-004 150 mg 11 None 33 206 59 206 View
Placebo Matching Placebo 5 None 21 206 59 206 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia of Chronic Disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Iron Deficiency Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
International normalised ratio abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chronic lymphocytic leukaemia recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View