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 @ 5:00 PM
Ignite Modification Date: 2025-12-25 @ 2:41 PM
NCT ID: NCT03103750
Description: Adverse events were collected at the individual level and were not distinguished at the stage of the crossover.
Frequency Threshold: 5
Time Frame: Up to 14 days
Study: NCT03103750
Study Brief: Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Calcitriol Then Placebo Healthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of calcitriol (3.0mcg total), followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of placebo for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4. Magnetic Resonance Imaging (MRI): Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject for the purposes of excluding participants with anatomical abnormalities and anatomically co-registering PET and MRI for image analysis PHNO: Used as a tracer for in vivo imaging. calcitriol: three 0.5 mcg capsules Placebo oral capsule: three 0.5 mcg capsules high-resolution research tomography: A functional imaging technique that is used to observe metabolic processes in the body. Dextro Amphetamine: Dexedrine 0.3 mg/kg, to a maximum dose of 30 mg 0 None 0 12 7 12 View
Placebo Then Calcitriol Healthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of placebo, followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of calcitriol (3.0mcg total) for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4. Magnetic Resonance Imaging (MRI): Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject for the purposes of excluding participants with anatomical abnormalities and anatomically co-registering PET and MRI for image analysis PHNO: Used as a tracer for in vivo imaging. calcitriol: three 0.5 mcg capsules Placebo oral capsule: three 0.5 mcg capsules high-resolution research tomography: A functional imaging technique that is used to observe metabolic processes in the body. Dextro Amphetamine: Dexedrine 0.3 mg/kg, to a maximum dose of 30 mg 0 None 0 12 6 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asymptomatic non-exclusionary bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension, asymptomatic and non-exclusionary NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mild transient nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mild anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mild insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea and vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View