Unique ID issued by UMIN | UMIN000036808 |
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Receipt number | R000041939 |
Scientific Title | Special drug use-results survey on ERLEADA 60 mg Tablets (Long-term use in patients with non-distant metastatic castration-resistant prostate cancer) |
Date of disclosure of the study information | 2019/05/31 |
Last modified on | 2023/08/02 16:07:02 |
Special drug use-results survey on ERLEADA 60 mg Tablets (Long-term use in patients with non-distant metastatic castration-resistant prostate cancer)
ELD1L
Special drug use-results survey on ERLEADA 60 mg Tablets (Long-term use in patients with non-distant metastatic castration-resistant prostate cancer)
ELD1L
Japan |
non-distant metastatic castration-resistant prostate cancer
Urology |
Malignancy
NO
To investigate the incidence of seizures and severe skin disorder in patients with non-distant metastatic castration-resistant prostate cancer who receive long-term treatment with ERLEADA 60 mg Tablets (hereinafter referred to as ERLEADA) in regular clinical practice.
Safety
[Patient composition]
(a) Number of patients registered
(b) Number of patients whose CRFs were collected
(c) Number of patients for safety analysis
(d) Number of patients excluded for analysis and the reason for exclusion
[Safety analysis]
(a) Incidence of safety specifications
(b) Factors considered affecting safety specification (incidence by patient background, etc.)
Observational
Not applicable |
Not applicable |
Male
Patients with non-distant metastatic castration-resistant prostate cancer who received ERLEADA for the first time are targeted.
The target patients must understand the contents of this survey and give consent to participation.
Patients with a history of the use of Apalutamide
200
1st name | Toshiya |
Middle name | |
Last name | Kato |
Janssen Pharmaceutical K.K.
Safety Risk Management Dept.
101-0065
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
03-4411-5478
tkato1@its.jnj.com
1st name | Sayuri |
Middle name | |
Last name | Harada |
Janssen Pharmaceutical K.K.
Safety Risk Management Dept.
101-0065
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
03-4411-5874
sharada8@its.jnj.com
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Profit organization
Janssen Pharmaceutical K.K.
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
03-4411-5874
sharada8@its.jnj.com
NO
2019 | Year | 05 | Month | 31 | Day |
Unpublished
218
No longer recruiting
2019 | Year | 04 | Month | 12 | Day |
2019 | Year | 04 | Month | 12 | Day |
2019 | Year | 05 | Month | 30 | Day |
2023 | Year | 11 | Month | 29 | Day |
Observation period: For 12 months (52 weeks) from the launch date for ERLEADA
2019 | Year | 05 | Month | 21 | Day |
2023 | Year | 08 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041939
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