Phase 3
Completed N=77
A Long Term Safety Study of Degarelix in Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00967018 ↗Enrolled (actual)
77
Serious AEs
6.5%
Results posted
Dec 2012
Primary outcomePrimary: Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables — 24; 6; 2; 1 Participants
Summary
Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables |
24; 6; 2; 1; 3; 1 | — |
| PRIMARY Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
1; 1; 1; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31
Exclusion Criteria
- Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31
Data sourced from ClinicalTrials.gov (NCT00967018). 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. Informational only — not medical advice.