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: 2025-12-25 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:02 AM
NCT ID: NCT02952820
Description: Placebo arm included AE data for participants who received placebo in Period 1. Lemborexant 5 mg and 10 mg arms included AE data of participants who received either lemborexant 5 mg or 10 mg throughout the study (Period 1 and 2 both) and participants re-randomized from placebo (in Period 1) to either lemborexant 5 mg or lemborexant 10 mg in Period 2.
Frequency Threshold: 5
Time Frame: From start of study drug administration up to Week 54
Study: NCT02952820
Study Brief: Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received placebo matched to lemborexant tablet, orally, once daily for up to 6 months. Then they were re-randomized to Lemborexant 5 mg or Lemborexant 10 mg. 0 None 5 319 75 319 View
Lemborexant 5 mg Participants received lemborexant 5 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 5 mg, tablets, orally, once daily through Month 7-12 (in Period 2). 0 None 18 447 129 447 View
Lemborexant 10 mg Participants received lemborexant 10 mg/placebo, tablets, orally, once daily through Month 1-6 (in Period 1) and lemborexant 10 mg, tablets, orally, once daily through Month 7-12 (in Period 2). 0 None 16 437 140 437 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Meniscus injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Intentional Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.0 View
Laryngeal Inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Dermal Cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Jaw Cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Floppy eyelid syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Alcoholic pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.0 View
Diabetic Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Lower Limb Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Pelvic Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Rib Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View
Type 2 Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Jaw Fistula SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Intraductal Proliferative Breast Lesion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Diabetic Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Disturbance In Attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Hydrosalpinx SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View