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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT02462603
Description: Safety population included any participant who received at least 1 dose of PTC589.
Frequency Threshold: 0
Time Frame: Baseline up to 30 days after last dose of study drug (up to 4 months)
Study: NCT02462603
Study Brief: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PTC589 Participants with Parkinson's disease (idiopathic and mitochondrial genetic subtype participants) received PTC589 at a dose of 500 mg (2 tablets of 250 mg each) orally BID for up to 3 months unless discontinued for safety or tolerability issues. 0 None 0 41 29 41 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Abnormal sensation in eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Ocular discomfort SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Plantar fasciitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Bradykinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hypogeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View