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 @ 4:41 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT01155466
Description: The safety population included all participants who received at least one dose of study drug
Frequency Threshold: 5
Time Frame: All adverse events: up to Week 14; serious adverse events: up to 30 days after the last dose of study drug (up to Week 16)
Study: NCT01155466
Study Brief: A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Preladenant 2 mg Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks None None 5 154 18 154 View
Preladenant 5 mg Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks None None 4 153 20 153 View
Preladenant 10 mg Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks None None 5 153 29 153 View
Placebo Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks None None 6 155 34 155 View
Rasagiline 1 mg Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks None None 9 154 25 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.1 View
Periproctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 15.1 View
Gilbert's syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA version 15.1 View
Hyperthermia malignant SYSTEMATIC_ASSESSMENT General disorders MedDRA version 15.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 15.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 15.1 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.1 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.1 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.1 View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 15.1 View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 15.1 View
Malignant melanoma stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 15.1 View
Oesophageal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 15.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 15.1 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 15.1 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 15.1 View
Hallucination, auditory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 15.1 View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 15.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 15.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.1 View
Pulmonary infarction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.1 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 15.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 15.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 15.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 15.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 15.1 View