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 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT01294800
Description: All Participants as Treated population, which included all participants who received at least one dose of study drug
Frequency Threshold: 5
Time Frame: Up to 14 weeks
Study: NCT01294800
Study Brief: A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)
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 Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks. None None 9 111 19 111 View
Preladenant 5 mg Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks. None None 5 113 23 113 View
Preladenant 10 mg Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks. None None 7 113 25 113 View
Placebo Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks. None None 3 113 14 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
LARGE INTESTINE POLYP SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
LOWER GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
DRUG-INDUCED LIVER INJURY SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
HEAT STROKE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
SPINAL COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
ULNA FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
JAW CYST SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
COLON CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
METASTASES TO LYMPH NODES SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
PARKINSON'S DISEASE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
IMPULSE-CONTROL DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
CYSTITIS HAEMORRHAGIC SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
ACTIVITIES OF DAILY LIVING IMPAIRED SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
DYSKINESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View