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 @ 7:56 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT02784704
Description: All serious adverse events by preferred term, Safety Population
Frequency Threshold: 3
Time Frame: 52 days
Study: NCT02784704
Study Brief: Efficacy and Safety Study of Eravacycline Compared With Meropenem 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
Meropenem Meropenem 1 g q8h 1 None 16 249 8 249 View
Eravacycline Eravacycline 1 mg/kg q12h 4 None 15 250 29 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Intestinal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Splenic hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 20.0 View
Abdominal wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
hydrothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Neuroendocrine tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Ureteric rupture SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gallbladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Pelvic fluid collection SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Peritonitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Suture related complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Wound decomposition SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Infusion site phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View