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 @ 10:19 PM
Ignite Modification Date: 2025-12-25 @ 7:52 PM
NCT ID: NCT02544035
Description: Adverse events were defined consistent with the clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: 1 year 11 months
Study: NCT02544035
Study Brief: Determining Age Appropriateness of Children's Products and Toys
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
12-18 Month-old Toy Type 12-18 month-olds (1-1.5 year olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category; 0 None 0 60 0 60 View
19-35 Month-old Toy Type 19-35 month-olds (1.5-2 year-olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category; 0 None 0 61 0 61 View
36-71 Month-old Toy Type 36-71 month-olds (3-5 year-olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category; 0 None 0 62 0 62 View
72-107 Month-old Toy Type 72-107 month-olds (6-8 year-olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category; 0 None 0 60 0 60 View
12-18 Month-old Play Partner 12-18 month-olds (1-1.5 year olds) Play Partner: Each child will first play alone then play with parent. 0 None 0 60 0 60 View
19-35 Month-old Play Partner 19-35 month-olds (1.5-2 year olds) Play Partner: Each child will first play alone then play with parent. 0 None 0 61 0 61 View
36-71 Month-old Play Partner 36-71 month-olds (1.5-2 year olds) Play Partner: Each child will first play alone then play with parent. 0 None 0 62 0 62 View
72-107 Month-old Play Partner 72-107 month-olds (6-8 year-olds) Play Partner: Each child will first play alone then play with parent. 0 None 0 60 0 60 View
Serious Events(If Any):
Other Events(If Any):