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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:46 PM
NCT ID: NCT01032135
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT01032135
Study Brief: Adaptive Treatment for Alcohol and Cocaine Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Engaged Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention. 0 None 34 227 0 227 View
MI-PC Non-engaged at 2 Weeks Participants start at IOP, but at 2 weeks are non-engaged. Randomized to treatment choice: Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day. 0 None 16 93 0 93 View
MI-IOP Non-Engaged at 2 Weeks Participants start at IOP, but at 2 weeks are non-engaged. Randomized to IOP Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out. 0 None 9 96 0 96 View
MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks. Randomized to treatment choice: Motivational Interviewing: 2 sessions at week 2 Telephone counseling: one telephone counseling session per week for 10 weeks. Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks. Medication Management: Prescription for naltrexone Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day. 1 None 4 41 0 41 View
MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks Initially engaged at IOP, but become non-engaged in weeks 3 - 8. Randomized to IOP Motivational Interviewing: 2 sessions at week 2 0 None 4 43 0 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalizations NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):