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 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT03036592
Description: None
Frequency Threshold: 0
Time Frame: During 9 days (1 day of intervention-1 week of washout-1 day of intervention), through study completion
Study: NCT03036592
Study Brief: MTNR1B SNP*Food Timing Interaction on Glucose Control
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Early OGTT (First) in MTNR1B CG Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early condition. After a washout period of 1 week, OGTT was performed in Late condition in a randomized cross-over study design. 0 None 0 193 0 193 View
Early OGTT (First) in MTNR1B CC Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early condition. After a washout period of 1 week, OGTT was performed in Late condition in a randomized cross-over study design. 0 None 0 221 0 221 View
Early OGTT (First) in MTNR1B GG Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early condition. After a washout period of 1 week, OGTT was performed in Late condition in a randomized cross-over study design. 0 None 0 36 0 36 View
Late OGTT (First) in MTNR1B CC Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Late condition. After a washout period of 1 week, OGTT was performed in Early condition in a randomized cross-over study design. 0 None 0 202 0 202 View
Late OGTT (First) in MTNR1B CG Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Late condition. After a washout period of 1 week, OGTT was performed in Early condition in a randomized cross-over study design. 0 None 0 149 0 149 View
Late OGTT (First) in MTNR1B GG Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Late condition. After a washout period of 1 week, OGTT was performed in Early condition in a randomized cross-over study design. 0 None 0 44 0 44 View
Late OGTT (Second) in MTNR1B CC Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early condition. After a washout period of 1 week, OGTT was performed in Late condition in a randomized cross-over study design. 0 None 0 221 0 221 View
Late OGTT (Second) in MTNR1B CG Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early condition. After a washout period of 1 week, OGTT was performed in Late condition in a 0 None 0 193 0 193 View
Late OGTT (Second) in MTNR1B GG Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early condition. After a washout period of 1 week, OGTT was performed in Late condition in a randomized cross-over study design. 0 None 0 36 0 36 View
Early OGTT (Second) in MTNR1B CC Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Late condition. After a washout period of 1 week, OGTT was performed in Early condition in a randomized cross-over study design. 0 None 0 202 0 202 View
Early OGTT (Second) in MTNR1B CG Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Late condition. After a washout period of 1 week, OGTT was performed in Early condition in a randomized cross-over study design. 0 None 0 149 0 149 View
Early OGTT (Second) in MTNR1B GG Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Late condition. After a washout period of 1 week, OGTT was performed in Early condition in a randomized cross-over study design. 0 None 0 44 0 44 View
Serious Events(If Any):
Other Events(If Any):