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 @ 2:47 PM
Ignite Modification Date: 2025-12-25 @ 1:15 PM
NCT ID: NCT01429259
Description: Laboratory (chemistry, complete blood count, liver function tests, urinalysis) systematically collected at baseline and end of therapy. Other adverse events documented when reported by the participant or on findings during physical examination.
Frequency Threshold: 0
Time Frame: Adverse Events collected from time of consent until completion of the study, which was 7-14 days after completion of meropenem prolonged infusion.
Study: NCT01429259
Study Brief: Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
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 3 Hour Prolonged Infusion All 30 participants will receive meropenem as a 3 hour infusion. meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion. None None 1 30 7 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocythemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
C-Reactive Protein Elevation SYSTEMATIC_ASSESSMENT Immune system disorders None View
Clostridium difficile Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Liver Function Test Abnormality SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View