Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Time frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)

Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.

Time frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)