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 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT03654404
Description: None
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT03654404
Study Brief: A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Positive Psychology Participants will receive check-in/psychosocial support phone calls at weeks four, eight and twelve following enrollment. At approximately 100-days post-HSCT, participants will begin an 8-week positive-psychology program involving weekly calls with an interventionist, in this case the principal investigator, and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). Participants will complete self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention. Positive Psychology Intervention: Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities. 1 None 1 20 0 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death due to complications related to hematopoietic stem cell transplantation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):