Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

Arms (1)

1. label

   VIZIMPRO(dacomitinib hydrate)

   description

   Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate)

   interventionNames

   1. Drug: dacomitinib hydrate

Primary outcomes (1)

1. measure

   The Number and Percentage of Participants With Interstitial Lung Disease (ILD)

   timeFrame

   52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).

   description

   An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis.