Trials / Completed
CompletedNCT02501330
Safety And Efficacy Of Bosutinib
DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 702 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 0 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this surveillance is to collect information about 1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3. factors considered to affect the safety and/or efficacy of this drug.
Detailed description
The patients should be registered by central registration system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosutinib | The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily. |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2024-02-28
- Completion
- 2024-02-28
- First posted
- 2015-07-17
- Last updated
- 2024-04-30
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02501330. Inclusion in this directory is not an endorsement.