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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT01280812
Description: None
Frequency Threshold: 0
Time Frame: 9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
Study: NCT01280812
Study Brief: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PA Intervention and Maintenance Plus 3-month physical activity intervention and 6-month maintenance intervention-Plus program Mobile phone based physical activity intervention with maintenance plus: This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary. 0 None 1 70 11 70 View
PA Intervention and Maintenance Regular 3-month physical activity intervention and 6-month maintenance intervention regular program Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to stop using the app (activity diary). 0 None 1 71 10 71 View
Control Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer. 0 None 3 69 6 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Infections and infestations None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Vascular disorders None View
Emergency Department or Urgent Care Facility Visits SYSTEMATIC_ASSESSMENT Eye disorders None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Emergency Department or Urgent Care Facility Visit SYSTEMATIC_ASSESSMENT Investigations None View