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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:56 PM
NCT ID: NCT01280968
Description: The number of participants at risk is different from the number of enrolled participants because not all participants who were randomized to a vaccine or placebo received treatment. Of the 52 participants who were assigned to a treatment group, only 41 received at least one vaccination. Therefore, 41 participants were at risk.
Frequency Threshold: 5
Time Frame: None
Study: NCT01280968
Study Brief: Improving the Efficacy of Anti-Nicotine Immunotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NIC002 Vaccine in Aluminum Hydroxide 4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide. None None 0 36 13 36 View
Placebo Vaccine - Aluminum Hydroxide 4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide. None None 0 5 3 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Weight Changes SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Feeling Cold SYSTEMATIC_ASSESSMENT General disorders None View
Feeling Hot SYSTEMATIC_ASSESSMENT General disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Runny Nose SYSTEMATIC_ASSESSMENT General disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Tenderness at Injection Site SYSTEMATIC_ASSESSMENT General disorders None View