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 @ 2:27 AM
Ignite Modification Date: 2025-12-26 @ 1:01 AM
NCT ID: NCT02015234
Description: 5% was used as the adverse event reporting cut-off
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT02015234
Study Brief: 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia 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
TNX-102 SL 2.8mg - TNX-102 SL 2.8 mg These patients received 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime during both the lead-in study (F202), as well as the open-label study, for a total treatment duration of up to 15 months. 0 None 5 79 39 79 View
Placebo - TNX-102 SL 2.8 mg These patients received placebo during the lead-in study (F202), followed by 1 x TNX-102 SL 2.8 mg tablet taken daily at bedtime for 12 months during the open-label study. 0 None 3 79 43 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intraductal proliferative breast lesion None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Abdominal hernia None Gastrointestinal disorders None View
Ankle fracture None Injury, poisoning and procedural complications None View
Brain stem glioma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pubic fracture None Injury, poisoning and procedural complications None View
Vertigo None Ear and labyrinth disorders None View
Malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Anxiety None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoaesthesia oral None Gastrointestinal disorders None View
Sinusitis None Infections and infestations None View
Fatigue None General disorders None View
Product taste abnormal None General disorders None View
Glossodynia None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Upper respiratory tract infection None Respiratory, thoracic and mediastinal disorders None View
Somnolence None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View