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 @ 7:13 PM
Ignite Modification Date: 2025-12-25 @ 4:48 PM
NCT ID: NCT05687903
Description: Safety Analysis Set included all participants who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: From first dose of the study drug up to end of the study (up to 3 months)
Study: NCT05687903
Study Brief: A Study of TAK-861 in Participants With Narcolepsy Type 1
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 tablets matching TAK-861, orally, BID, from Days 1 to 56. 0 None 0 22 5 22 View
TAK-861 0.5 mg BID Participants received TAK-861 0.5 mg, orally, BID, from Days 1 to 56. 0 None 0 23 11 23 View
TAK-861 2 mg BID Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56. 0 None 0 21 15 21 View
TAK-861 2 mg/5 mg Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56. 0 None 1 23 20 23 View
TAK-861 7 mg QD Participants received TAK-861 7 mg, orally, QD, from Days 1 to 56. Placebo was given as the second dose. 0 None 0 23 20 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.1 View
Middle insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.1 View