44-302 : Special Drug Use-Results Survey of VELEXBRU (WM/LPL)

JRCT ID: jRCT2011210005

Registered date:28/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Waldenstrom macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LPL)
• Date of first enrollment: 03/09/2020
• Target sample size: 60
• Study type: Observational

Outcome(s)

Primary Outcome

Occurrence status of adverse drug reactions and infections, Occurrence status of adverse drug reactions corresponding to specified safety concerns, Factors that are considered to affect safety
Specified safety concerns: Infections,Severe skin disorders, Myelosuppression, Hypersensitivity, Interstitial lung diseases, Hepatic function disorders, Hemorrhage

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: All patients with WM/LPL for whom VELEXBLU is administered
• Exclude criteria: patients who have not received VELEXBLU

Related Information

• Primary Sponsor: Kuro Toshihiko