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 @ 4:03 PM
Ignite Modification Date: 2025-12-25 @ 2:05 PM
NCT ID: NCT02732366
Description: Although falls were expected in this study, they were collected.
Frequency Threshold: 0
Time Frame: From baseline to 6 months from baseline
Study: NCT02732366
Study Brief: Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention 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
Group-based Exercise and Peer Coaching This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring. Group-based exercise and peer coaching: Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring. 0 None 0 18 10 18 View
Usual PT and Attention Control Grp Class This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class. Usual PT and attention control grp class: The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions). 0 None 2 21 10 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
spine disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Falls SYSTEMATIC_ASSESSMENT General disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View