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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT02447718
Description: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse Events were not monitored for Healthy Controls as they did not receive the interventions, they provided baseline data only.
Frequency Threshold: 0
Time Frame: AEFI was captured through structured telephone interviews on days 8-10 and 30-33 after each immunization
Study: NCT02447718
Study Brief: Vaccinating Children After Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DTaP-IPV-HiB+PCV13 DTaP-IPV-Hib: diphtheria-tetanus-acellular pertussis-inactivated polio-H. influenzae type b vaccine PCV13: 13-valent pneumococcal conjugate vaccine 0 None 0 74 56 74 View
PPV23 PPV23: 23-valent pneumococcal polysaccharide vaccine 0 None 0 73 46 73 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain/erythema/swelling at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Systemic symptoms SYSTEMATIC_ASSESSMENT General disorders None View