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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT05603312
Description: Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Frequency Threshold: 5
Time Frame: From the signing of the Informed Consent Form to Week 26
Study: NCT05603312
Study Brief: A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AAV-GAD Low Dose Bilateral infusion of AAV-GAD Low Dose into the STN 0 None 2 5 5 5 View
AAV-GAD High Dose Bilateral infusion of AAV-GAD High Dose into the STN 0 None 0 5 5 5 View
Sham Surgery Sham infusion 0 None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Freezing phenomenon SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders None View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Confusion postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eye contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Computerised tomogram abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations None View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations None View
Reflex test abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle rigidity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Torticollis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial spasm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Head discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperreflexia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
On and off phenomenon SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View