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 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:29 AM
NCT ID: NCT01161160
Description: The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Frequency Threshold: 5
Time Frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182).
Study: NCT01161160
Study Brief: Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arepanrix 1/2 Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. 0 None 1 76 52 76 View
Pandemrix 1/2 Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. 0 None 0 75 52 75 View
Arepanrix Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. 0 None 1 58 35 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dengue fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue (6-10Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cough (Days 0-41 post-vacc.) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Conjunctivitis (Days 0-41 post-vacc.) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Pyrexia (Days 0-20 post-vacc.) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia (Days 0-41 post-vacc.) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Drowsiness (3-5Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Irritability (3-5Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Loss of appetite (3-5Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Temperature/Axillary (3-5Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Headache (6-10Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Joint pain (6-10Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Muscle aches (6-10Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Shivering (6-10Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Temperature/Axillary (6-10Y) SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Upper respiratory tract infection (Days 0-20 post-vacc.) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis (Days 0-20 post-vacc.) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis (Days 0-20 post-vacc.) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Nasopharyngitis (Days 0-41) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection (Days 0-41 post-vacc.) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis (Days 0-41 post-vacc.) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View