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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT02388295
Description: Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Frequency Threshold: 1
Time Frame: 12 weeks of randomized treation plus a follow up period up to 14 days after last dose
Study: NCT02388295
Study Brief: AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD3241 600 mg AZD3241 600 mg dosed twice daily None None 1 20 15 20 View
Placebo Placebo to match AZD3241 dosed twice daily None None 1 19 14 19 View
AZD3241 300 mg AZD3241 300 mg dosed twice daily None None 1 19 15 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Multipla System Atrophy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Adverse drug reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Feeling jittery NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Administration related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Thermal burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle fatigue NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Balance disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Clumsiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depressive symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypokinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine with aura NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Radicular pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Restless leg syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Abnormal dreams NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Disorientation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sleep apnoe syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin discolouration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin lesion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin necrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alcohol use NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA View
atrial fibrilation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View