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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:46 PM
NCT ID: NCT02358135
Description: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02358135
Study Brief: Collaborative Connected Health (CCH) for PCORI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
In-Person Model (Control) The control arm is the in-person model. Patients randomized to the in-person arm sought psoriasis care from Primary Care Physicians (PCPs) or dermatologists in person. 1 None 15 148 51 148 View
Online Model (Collaborative Connected-Health) The intervention arm is the online, collaborative connected-health model: an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. The collaborative connected-health model was designed such that any specialist services that usually occur in person could be delivered through asynchronous online healthcare in a flexible and prompt manner. In this pragmatic trial, the PCPs could access the dermatologists online asynchronously via consultation or requesting a dermatologist to assume care of a patient's psoriasis. Patients randomized to the online group had the option of accessing dermatologists online asynchronously. During an online visit, the patient would upload clinical images and history and transmit the information to the dermatologist. Using the telehealth platform, the dermatologist would review the transmitted information, make treatment recommendations, prescribe medications, and provide educational materials 1 None 12 148 42 148 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious Adverse Event SYSTEMATIC_ASSESSMENT General disorders None View
Serious Adverse Event SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Serious Adverse Event SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Serious Adverse Event SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General adverse event SYSTEMATIC_ASSESSMENT General disorders None View