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 @ 5:12 PM
Ignite Modification Date: 2025-12-25 @ 2:50 PM
NCT ID: NCT03485950
Description: None
Frequency Threshold: 5
Time Frame: From the date of the first dose of IV study drug to 30 days following the last dose of study drug. All patients were followed until last follow up which occurred 35-42 days following the first dose of study drug.
Study: NCT03485950
Study Brief: Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care (SOC) Arm Received one of the following IV therapies: Cefepime (minimum of 9 doses), Meropenem (minimum of 9 doses), Piperacillin/Tazobactam (minimum of 12 doses). Patients may receive other additional therapy. 2 None 33 50 6 50 View
Ceftolozane/Tazobactam Arm Received IV Ceftolozane/Tazobactam (minimum of 9 doses). Patients may receive other additional therapy. 3 None 33 47 9 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bilirubin increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bloodstream infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Papilledema SYSTEMATIC_ASSESSMENT Eye disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Retroperitoneal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Splenic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral hepatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View