UMIN ID: UMIN000028897
Registered date:01/11/2017
ZALTRAP Special Drug Use Surveillance (Unresectable advanced and/or recurrent colorectal cancer)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | colorectal cancer |
| Date of first enrollment | 2017/12/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Safety: Incidence rate of adverse drug reaction Effectiveness: Tumor assessment |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients concurrently participating in any interventional clinical studies |
Related Information
| Primary Sponsor | Sanofi K.K. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sanofi K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Public contact for Drug use surveillance - |
| Address | 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan Japan 163-1488 |
| Telephone | 03-6301-3867 |
| Sanofi_Medical@sanofi.com | |
| Affiliation | Sanofi K.K. Post-marketing regulatory study, Medical Affairs |
| scientific contact | |
| Name | Katsuhisa SUZUKI |
| Address | 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan Japan |
| Telephone | 03-6301-3867 |
| Sanofi_Medical@sanofi.com | |
| Affiliation | Sanofi K.K. Post-marketing regulatory study, Medical Affairs |