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 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
NCT ID:
NCT00770692
Description:
None
Frequency Threshold:
2
Time Frame:
None
Study:
NCT00770692
Study Brief:
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Eszopiclone 3 mg- Non-elderly | Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. | None | None | 2 | 77 | 67 | 77 | View |
| Eszopiclone 1 mg- Elderly | Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment. | None | None | 3 | 81 | 66 | 81 | View |
| Eszopiclone 2 mg Elderly | Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. | None | None | 3 | 83 | 66 | 83 | View |
| Eszopiclone 2 mg- Non-elderly | Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment. | None | None | 2 | 84 | 69 | 84 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Acute myocardial infarction | None | Cardiac disorders | MedDRA (13.0) | View |
| Clavicle fracture | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Type 1 diabetes mellitus | None | Endocrine disorders | MedDRA (13.0) | View |
| Major depressive disorder | None | Psychiatric disorders | MedDRA (13.0) | View |
| Loss of consciousness | None | Nervous system disorders | MedDRA (13.0) | View |
| Oesophagitis haemorrhagic | None | Vascular disorders | MedDRA (13.0) | View |
| Calculus ureteric | None | Renal and urinary disorders | MedDRA (13.0) | View |
| Heat illness | None | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Completed suicide | None | Psychiatric disorders | MedDRA (13.0) | View |
| Sick sinus syndrome | None | Cardiac disorders | MedDRA (13.0) | View |
| Angina pectoris | None | Vascular disorders | MedDRA (13.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysgeusia | None | Nervous system disorders | MedDRA (13.0) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (13.0) | View |
| Headache | None | Nervous system disorders | MedDRA (13.0) | View |
| Somnolence | None | Nervous system disorders | MedDRA (13.0) | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA (13.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA (13.0) | View |
| Thirst | None | General disorders | MedDRA (13.0) | View |
| Glucose urine present | None | Investigations | MedDRA (13.0) | View |
| Dizziness | None | Nervous system disorders | MedDRA (13.0) | View |
| Pharyngitis | None | Infections and infestations | MedDRA (13.0) | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Abdominal discomfort | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gastritis | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Stomatitis | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal Pain | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal Pain Upper | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Oral Discomfort | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Reflux Oesophagitis | None | Gastrointestinal disorders | MedDRA (13.0) | View |
| Malaise | None | General disorders | MedDRA (13.0) | View |
| Hepatic Function Abnormal | None | Hepatobiliary disorders | MedDRA (13.0) | View |
| Bronchitis | None | Infections and infestations | MedDRA (13.0) | View |
| Cystitis | None | Infections and infestations | MedDRA (13.0) | View |
| Influenza | None | Infections and infestations | MedDRA (13.0) | View |
| Contusion | None | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Thermal Burn | None | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Alanine Aminotransferase Increased | None | Investigations | MedDRA (13.0) | View |
| Blood Triglycerides Increased | None | Investigations | MedDRA (13.0) | View |
| Eosinophil Count Increased | None | Investigations | MedDRA (13.0) | View |
| Gamma-glutamyltransferase Increased | None | Investigations | MedDRA (13.0) | View |
| White Blood Cell Count Increased | None | Investigations | MedDRA (13.0) | View |
| Blood Urine Present | None | Investigations | MedDRA (13.0) | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Musculoskeletal Pain | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Musculoskeletal Stiffness | None | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Sciatica | None | Nervous system disorders | MedDRA (13.0) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (13.0) | View |
| Dermatitis Contact | None | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Eczema | None | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Hypertension | None | Vascular disorders | MedDRA (13.0) | View |