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 @ 11:17 PM
Ignite Modification Date: 2025-12-25 @ 8:55 PM
NCT ID: NCT01844856
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT01844856
Study Brief: Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eravacycline, 1.0 mg/kg q12h Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days. None None 17 270 43 270 View
Ertapenem, 1.0 g q24h Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days. None None 16 268 28 268 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Intestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Oesophageal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pancreatitis necrotising SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Haematoma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Peritoneal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Abdominal wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Gastrointestinal stoma complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Splenic rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Wound evisceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pulmonary artery thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Biliary drainage SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Pulseless electrical activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Abdominal compartment syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View