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 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT02421120
Description: Laboratory (chemistry, complete blood count, liver function tests, urinalysis) were completed systematically prior to first dose and within 24 hours after completion of the final pharmacokinetic blood sample. All other adverse events collected when reported by the participant or during daily physical examination.
Frequency Threshold: 0
Time Frame: Adverse events were collected over the course of the 3 day study.
Study: NCT02421120
Study Brief: Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ceftolozane/Tazobactam Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses Ceftolozane/Tazobactam: 1 hour intravenous infusion 0 None 0 21 4 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders None View
Liver Function Test Elevation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Vaginal Itching NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Type I Hypersensitivity Reaction NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View