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 @ 12:15 PM
Ignite Modification Date: 2025-12-26 @ 12:15 PM
NCT ID: NCT01467700
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: Approximately 30 days after the last dose of study drug (up to 12 Weeks)
Study: NCT01467700
Study Brief: Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder
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 Ramelteon SL placebo-matching, tablets, sublingual (SL) \[dissolved under the tongue\], once daily, every night at bedtime for up to 8 weeks. None None 4 115 10 115 View
Ramelteon SL 0.1 mg Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks. None None 5 127 17 127 View
Ramelteon SL 0.4 mg Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks. None None 3 124 19 124 View
Ramelteon SL 0.8 mg Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks. None None 1 123 19 123 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.1) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.1) View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (17.1) View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.1) View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.1) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.1) View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View