UMIN ID: UMIN000054267
Registered date:27/04/2024
Pegfilgrastim subcutaneous injection 3.6mg Drug use results survey -Prevention of chemotherapy-induced febrile neutropenia-
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients who received pegfilgrastim for the first time to prevent of chemotherapy-induced febrile neutropenia |
| Date of first enrollment | 2015/08/26 |
| Target sample size | 1500 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Consider the following safety issues -Side effects/infectious diseases (types, incidence, etc.) -Factors that may affect safety -Serious adverse events -Safety specifications Consider the following effectiveness issues -Febrile neutropenia -Changes in neutrophil count -Examination of factors thought to influence changes in neutrophil count and the onset of febrile neutropenia |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | -If a contract with the facility has not been concluded -If the start date of Pegfilgrastim administration is outside the contract period -If there are duplicate registered cases (already registered) -If the number of registrations exceeds the number of contracted cases -If the case is registered after Pegfilgrastim administration -If registered by a doctor other than the contracted doctor |
Related Information
| Primary Sponsor | Kyowa Kirin Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyowa Kirin Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroshi Kuwazawa |
| Address | Otemachi Financial City Grand Cube 1-9-2 Otemachi, Chiyoda-ku, Tokyo Japan 100-0004 |
| Telephone | 07031439628 |
| hiroshi.kuwazawa.wd@kyowakirin.com | |
| Affiliation | Kyowa Kirin Co., Ltd. Pharmacovigilance Division |
| scientific contact | |
| Name | Nobuhiro Shibata |
| Address | 3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan |
| Telephone | +81(0)72-804-0101 |
| shibanob@hirakata.kmu.ac.jp | |
| Affiliation | Kansai Medical University Hospital Cancer Treatment Center |