Overall survival (OS)
Oncologyยท appears in 400+ cited findings in this library
What it is and how the reviews use it
Overall survival (OS) is a key endpoint used in FDA and EMA regulatory review documents to measure the length of time from a specific point (such as the start of treatment or diagnosis) until death from any cause. It is a critical measure of treatment efficacy in clinical trials, often serving as a primary or secondary endpoint.
In the reviewed documents, OS is frequently reported as a median duration in months, a percentage at a specific time point, or as a Hazard Ratio (HR). For instance, the ASTRAZENECA โ Faslodex FDA Review reported a median OS of 22.8 months, while the Bristol-Myers Squibb Company โ Sprycel EMA EPAR variation assessment report noted an Overall survival (OS) at 5 years after last dose of 79.4%. The ELI LILLY AND CO โ Lartruvo FDA Review presented an Overall Survival Hazard Ratio of 0.52.
Real examples โ cited to the source page
| ASTRAZENECA โ Faslodex | median OS (months) | 22.8 | Faslodex FDA Review, p.41 |
| BAYER HLTHCARE โ Stivarga | OS Hazard Ratio | 0.63 | Stivarga FDA Review, p.190 |
| Bristol-Myers Squibb Company โ Sprycel | Overall survival (OS) at 5 years after last dose | 79.4 | Sprycel EMA EPAR variation assessment r, p.11 |
| Incyte Corporation โ Minjuvi | OS rate (%) at 12 months for placebo+R2 | 93.7 | Minjuvi EMA EPAR variation assessment report, p.68 |
| Astellas Pharma Inc. โ Xtandi | HR for overall survival | 0.633 | Xtandi EMA EPAR public assessment report, p.66 |
| Cstone โ Cejemly | Median OS (months) in sugemalimab+chemotherapy arm | 25.4 | Cejemly EMA EPAR public assessment report, p.91 |
| Teva B V โ Trisenox | overall survival (OS) at 3 years (standard arm) | 77 | Trisenox EMA EPAR variation assessment report, p.10 |
| Merck & Co., Inc. โ Keytruda | median overall survival (months) | 20.0 | Keytruda FDA Review, p.77 |
Different drugs were studied in different trials โ these values are not head-to-head comparisons.
Explore the full evidence
Every Overall finding in the library โ searchable and answerable in plain language โ is in the Oncology research library โ
Figures are as stated in the cited source documents. Educational reference only โ not medical or investment advice.