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 @ 5:37 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT01737268
Description: None
Frequency Threshold: 0
Time Frame: From first dose of study drug up to week 52 (52 weeks)
Study: NCT01737268
Study Brief: Long-term Study of FK949E in Elderly Bipolar Disorder Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FK949E Elderly Participants After 2 days of dose-titration, elderly participants received either FK949E 150 mg or FK949E 300 mg once daily at bedtime from day 3 to week 52. Dose increase and reduction was allowed following dose increase or reduction guidelines and at the investigator's discretion. After which, participants went through a follow-up period of 1 week. For participants, who completed or discontinued treatment at FK949E 300 mg, a dose-tapering period was placed before proceeding to the follow-up period, and FK949E 150 mg was administered once daily for 1 week in this period. 0 None 2 20 18 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Malaise None General disorders MedDRA/J v18.0 View
Depression None Psychiatric disorders MedDRA/J v18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypothyroidism None Endocrine disorders MedDRA/J v18.0 View
Abdominal pain None Gastrointestinal disorders MedDRA/J v18.0 View
Constipation None Gastrointestinal disorders MedDRA/J v18.0 View
Gastritis None Gastrointestinal disorders MedDRA/J v18.0 View
Nausea None Gastrointestinal disorders MedDRA/J v18.0 View
Salivary hypersecretion None Gastrointestinal disorders MedDRA/J v18.0 View
Fatigue None General disorders MedDRA/J v18.0 View
Malaise None General disorders MedDRA/J v18.0 View
Thirst None General disorders MedDRA/J v18.0 View
Influenza None Infections and infestations MedDRA/J v18.0 View
Nasopharyngitis None Infections and infestations MedDRA/J v18.0 View
Fall None Injury, poisoning and procedural complications MedDRA/J v18.0 View
Wound None Injury, poisoning and procedural complications MedDRA/J v18.0 View
Blood creatine phosphokinase increased None Investigations MedDRA/J v18.0 View
Blood glucose decreased None Investigations MedDRA/J v18.0 View
Blood prolactin increased None Investigations MedDRA/J v18.0 View
Blood thyroid stimulating hormone increased None Investigations MedDRA/J v18.0 View
Blood triglycerides increased None Investigations MedDRA/J v18.0 View
Blood uric acid increased None Investigations MedDRA/J v18.0 View
Liver function test abnormal None Investigations MedDRA/J v18.0 View
Weight decreased None Investigations MedDRA/J v18.0 View
Platelet count increased None Investigations MedDRA/J v18.0 View
Back pain None Musculoskeletal and connective tissue disorders MedDRA/J v18.0 View
Muscle spasms None Musculoskeletal and connective tissue disorders MedDRA/J v18.0 View
Musculoskeletal stiffness None Musculoskeletal and connective tissue disorders MedDRA/J v18.0 View
Dizziness None Nervous system disorders MedDRA/J v18.0 View
Dizziness postural None Nervous system disorders MedDRA/J v18.0 View
Dysarthria None Nervous system disorders MedDRA/J v18.0 View
Dysgeusia None Nervous system disorders MedDRA/J v18.0 View
Headache None Nervous system disorders MedDRA/J v18.0 View
Movement disorder None Nervous system disorders MedDRA/J v18.0 View
Somnolence None Nervous system disorders MedDRA/J v18.0 View
Depression None Psychiatric disorders MedDRA/J v18.0 View
Intentional self-injury None Psychiatric disorders MedDRA/J v18.0 View
Rosacea None Skin and subcutaneous tissue disorders MedDRA/J v18.0 View
Hypertension None Vascular disorders MedDRA/J v18.0 View
Gait disturbance None General disorders MedDRA/J v18.0 View