N/A
N=148
Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01099267 ↗Enrolled (actual)
148
Serious AEs
—
Results posted
Nov 2011
Primary outcome: Primary: Participants Survival Status as of the Time of the Extension Study Follow-up — 101; 29; 18 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Survival Status as of the Time of the Extension Study Follow-up |
101; 29; 18 | — |
| PRIMARY Kaplan Meier Estimate for Overall Survival |
39.47 | — |
| PRIMARY Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up |
36; 86; 25 | — |
| PRIMARY Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML) |
NA | — |
| PRIMARY Cause of Death for Participants Who Died |
24; 7; 9; 4; 3; 9 | — |
Summary
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
Eligibility Criteria
Inclusion Criteria
- Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
- Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data).
Exclusion Criteria
- Consent refused for any reason at current or long-term follow up completed in 2007 (long-term follow up: survival data collection completed to obtain further safety information on CC-5013-MDS-003 discontinued subjects from May - October 2007).
Data sourced from ClinicalTrials.gov (NCT01099267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.