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: NCT01922934
Description: The definitions used by clinicaltrials.gov for adverse event and serious adverse event apply. Adverse events were only collected and reported on the intervention arm only and not on the control arm, as those in the control participated passively by a waiver of consent and never had any interaction with the study team or knowledge of the study's existence. This waiver was approved by the IRB.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time the first patient in the intervention arm received a tool at their study visit #1 (1/14/2015) through when the final study patient was seen for receiving a tool at their study visit #12 (8/12/2016). Thus, adverse events were collected over a period of 19 months. Adverse events were not collected on those in the control arm; those subjects participated passively by a waiver of consent and never had any interaction with the study team.
Study: NCT01922934
Study Brief: A Toolbox Approach to Obesity Treatment in Primary Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention 428 randomly-selected patients from four Denver Health clinics were selected to be offered a "toolbox" of weight loss options, including: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes \& entrees); and obesity pharmacotherapy (Qsymia \& phentermine) for a $5-$10 co-pay for the therapies. Of these 428 patients, 140 came in and consented at the computer program visit at which these options were offered. 119 of these patients came in for a visit one where they received their tool for the first time. Adverse events from the group of 140 patients who consented to receive the intervention are reported. 1 None 1 140 9 140 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death occurring after being lost to follow up for a year on meal replacement tool NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fainting on Qsymia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression on Qsymia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety/Chest Pain on Qsymia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
GERD causing chest pain on Qsymia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unknown chest pain on Qsymia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Eye pain on Qsymia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
CVA (stroke) on Weight Watchers NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Alcohol withdrawal symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View