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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT02165904
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT02165904
Study Brief: Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Autologous Mesenchymal Bone Marrow Cell Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\^6 cells for each patient 0 None 1 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (18.1) View
Infected pressure ulcer SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Pain in coccyx SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Nasopharingytis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.1) View