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 @ 2:37 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT02050334
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02050334
Study Brief: CC100: Safety and Tolerability of Single Doses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CC100 (2 Single Doses) & Placebo(1 Dose) CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 Placebo None None 0 9 4 9 View
CC100 (3 Single Doses) CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 None None 0 9 3 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
urinary tract infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View