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 @ 4:43 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT04470518
Description: Admission to hospital at the index consultation + Admission to hospital day 1-30
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT04470518
Study Brief: Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention: Diagnostic Algorithm diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice diagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)). 0 None 0 2988 32 2988 View
Usual Care In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children"). 0 None 0 3762 64 3762 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hospitalisation NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View