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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT02451358
Description: A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Frequency Threshold: 5
Time Frame: Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
Study: NCT02451358
Study Brief: Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28. 0 None 0 100 29 100 View
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28. 0 None 0 100 50 100 View
Quadrivalent Influenza Vaccine Group 4: >=18 Years Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0. 0 None 0 100 24 100 View
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0. 0 None 0 100 44 100 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDra 18.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDra 18.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 18.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 18.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 18.0 View