Advanced ovarian, breast, or prostate cancer
Conditions
Brief summary
1. Safety will be evaluated based on the incidence of treatment emergent AEs (TEAEs; including treatment discontinuation and dose modifications due to AEs), SAEs, AESIs, changes in ECOG performance status, changes in clinical laboratory assessments (hematology, chemistry), vital sign measurements, observations during physical examination, and use of concomitant medications (...)., 2. (excluding any study drugs used in the parent study) All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedRA) coding system outlined in the statistical analysis plan.
Interventions
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety will be evaluated based on the incidence of treatment emergent AEs (TEAEs; including treatment discontinuation and dose modifications due to AEs), SAEs, AESIs, changes in ECOG performance status, changes in clinical laboratory assessments (hematology, chemistry), vital sign measurements, observations during physical examination, and use of concomitant medications (...)., 2. (excluding any study drugs used in the parent study) All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedRA) coding system outlined in the statistical analysis plan. | — |
Countries
Austria, France, Italy, Spain
Outcome results
None listed