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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT01058304
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected during each participant's study period, which was six months.
Study: NCT01058304
Study Brief: Group Physical Therapy for Knee Osteoarthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 Group Physical Therapy for Knee OA Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program. None None 1 159 8 159 View
Arm 2 Individual Physical Therapy for Knee OA Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program. None None 0 161 8 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospital Admission NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Investigations None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other event NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Outpatient Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Emergency Room Visit NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View