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 @ 3:44 AM
Ignite Modification Date: 2025-12-26 @ 2:30 AM
NCT ID: NCT02368002
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT02368002
Study Brief: BestFIT: a Personalized Weight Loss Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Week 3 Treatment Response Assessment Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs. 0 None 0 233 0 233 View
Week 7 Treatment Response Assessment Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs. 0 None 3 235 0 235 View
Portion Controlled Meals Portion controlled meals: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to portion controlled meals. 0 None 1 132 0 132 View
Acceptance-based Treatment Acceptance-based treatment: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to acceptance-based treatment. 0 None 2 127 0 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depressive disorders NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ovarian cancer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Dehydration & Hypertension NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Other Events(If Any):