In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
Study Type
OBSERVATIONAL
Enrollment
1,605
20mg - 50mg
Incidence of Adverse Drug Reactions (ADRs)
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
Time frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.
Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]
Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor \[TKI\]-naïve patients and the TKI pre-treated patients. Overall response was calculated with 95% Clopper-Pearson confidence interval. OR = (CR+PR)/(CR+PR+SD+PD+Unknown)\*100.
Time frame: 52 weeks.
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Boehringer Ingelheim Investigational Site 145
Adachi Tokyo, Japan
Boehringer Ingelheim Investigational Site 429
Aira Kagoshima, Japan
Boehringer Ingelheim Investigational Site 64
Aizuwakamatsu Fukushima, Japan
Boehringer Ingelheim Investigational Site 44
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 45
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 46
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 47
Akita Akita, Japan
Boehringer Ingelheim Investigational Site 333
Amagasaki Hyogo, Japan
Boehringer Ingelheim Investigational Site 266
Anjo Aichi, Japan
Boehringer Ingelheim Investigational Site 27
Aomori Aomori, Japan
...and 422 more locations