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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT03022032
Description: Only death and serious adverse events were assessed for the SMART Study Arm.
Frequency Threshold: 0
Time Frame: HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days
Study: NCT03022032
Study Brief: The HOPE Trial and the SMART Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HOPE Pre-Pilot 10 patients will be enrolled in stage 1 to refine the HOPE App intervention; All participants will receive: HOPE App, The Fitbit Zip, The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2. Fitbit Zip: Fitbit Zip HOPE App: HOPE App Fitbit Charge 2: Fitbit Charge 2 0 None 0 10 10 10 View
Refined Smartphone App and Accelerometer (HOPE) Participants received the Fitbit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. 0 None 0 23 22 23 View
Wearable Accelerometer (HOPE) Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data. 0 None 0 21 19 21 View
Refined Smartphone App (HOPE) Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. 0 None 0 22 21 22 View
Usual Care (HOPE) The HOPE app will collect passive data from the smartphone. 2 None 0 22 18 22 View
SMART Study Arm Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms. 0 None 0 4 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomit NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View