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: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT02968433
Description: Adverse events were categorized using the CTCAE v4.0.
Frequency Threshold: 0
Time Frame: Adverse events were monitored during the entirety of the trial, starting at baseline and continuing through the 4 week post-infusion mark (8 week total).
Study: NCT02968433
Study Brief: The Stanford Parkinson's Disease Plasma 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
Infusions of Young Plasma All participants will undergo neuropsychological, neuropsychiatric, and kinematic assessments prior to receiving infusions of young plasma as the treatment. Participants will receive 1 unit of young plasma, twice a week over a four week duration. After the four weeks of plasma infusions, participants will undergo neuropsychological, neuropsychiatric and kinematic reassessments. No deception will be used. Infusions of young plasma: Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25) 0 None 0 16 13 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bruising SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nervous system disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary frequency distrubance SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tissue disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest tightness SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Tremor SYSTEMATIC_ASSESSMENT General disorders None View
Involuntary movement SYSTEMATIC_ASSESSMENT General disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sleep disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT General disorders None View