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 @ 10:47 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT01963169
Description: Other Adverse Events: Specific adverse event terms are not collected (Reported as "Not associated/unlikely to be associated to the investigational product/procedure, Unexpected")
Frequency Threshold: 0
Time Frame: 12 months (throughout the data collection period)
Study: NCT01963169
Study Brief: Dissemination of a Theory-Based Bone Health Program in Online
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TO-BoneHealth Group The group will use the 8-week TO-BoneHealth program, which includes: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys. TO-BoneHealth Program (Bone Power Program): The 8-week TO-BoneHealth program include: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. 0 None 0 301 14 301 View
TO-BoneHealth Plus Group The group will use the TO-BoneHealth Plus program intervention, which includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months. TO-BoneHealth Plus Program (Bone Power Plus Program): This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months. 0 None 0 302 25 302 View
Control Group No specific intervention will be provided to the control group participants. To keep in contact with participants, a monthly e-mail will be sent to inform them of upcoming follow-up surveys. At the end of the study (upon completion of all five surveys), the control group participants will receive a CD version of the TO-BoneHealth program via mail. 0 None 0 263 7 263 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Not associated/unlikely to be associated to the investigational product/procedure, Unexpected NON_SYSTEMATIC_ASSESSMENT General disorders None View