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 @ 5:00 AM
Ignite Modification Date: 2025-12-26 @ 4:00 AM
NCT ID: NCT04799418
Description: The clinicaltrials.gov definitions of AE and SAE were used
Frequency Threshold: 5
Time Frame: 8 months
Study: NCT04799418
Study Brief: STEM-PD Open Label Extension (OLE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Passive-active This group received passive treatment with the study device in a randomized controlled trial that immediately preceded this open label extension trial during which participants received active (i.e., time-varying caloric vestibular stimulation) treatment. Treatment was \~20 minutes, 2x per day for 12 weeks, then a follow-up period without treatment for 16 weeks, then another 8 week treatment period with the active treatment. 1 None 7 69 51 69 View
Experimental: Active-active This group received active (i.e. time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial that immediately preceded this open label extension trial during which participants received active treatment. Data obtained from this group was only utilized for exploratory outcome measures. Treatment was \~20 minutes, 2x per day for 12 weeks, then a follow-up period without treatment for 16 weeks, then another 8 week treatment period with the active treatment. 1 None 6 79 42 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Bilateral Pleural Effusions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Cerebral Vascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Right Knee Replacement surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Multiple Myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Skin Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Partial Small Bowl Obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Acute Gastroenteritis with Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
ESCHERICHIA COLI URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Weakness secondary to urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Medical device site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View