... unplanned survival analysis, conducted when 77% of events had been observed (see Figure 1), was consistent with the primary ... Table 5: Comparison of Overall Survival in HALAVEN and Control Arm - Study 1 Overall Survival. HALAVEN (n=508). Control Arm (n= ... Age, Sex, and Race/Ethnicity: Based on a population pharmacokinetic analysis, no clinically meaningful differences in the ... In Study 1, a statistically significant improvement in overall survival was observed in patients randomized to the HALAVEN arm ...

Many trials just reported on differences in progression-free survival or overall survival at the end of a set time frame, but ... analysis of various results, such as Kaplan-Meier Curves, reveal Lenvima appears to start working after 2 months, for cancers ... Lenvima, a cancer medicine taken by mouth, has been shown in studies to extend progression-free survival (PFS) in kidney, liver ... overall survival (OS), was found to be non-inferior (13.6 months with lenvatinib vs 12.3 months with sorafenib). Lenvatinib did ...

Progression-free survival. (years). Event-free survival. (years). Time to treatment failure. (years). ... The population PK analysis in adults with GPA and MPA showed that male patients and patients with higher BSA or positive anti- ... The primary analysis was at the end of the 6 month remission induction period and the safety results for this period are ... In exploratory analyses defined by age, there was no observed benefit from the addition of rituximab to fludarabine and ...

With a median follow-up of 28.3 months, median overall survival was not reached in any arm, with fewer than 10% of patients ... The pre-specified type I error rate (α) for this interim analysis is 0.012 derived from a Lan-DeMets alpha spending function ... With a median follow up of 16.1 months, median overall survival was not reached in either arm, with fewer than 11% of patients ... No effects on embryo-fetal development and survival were observed. The AUC at 200 mg/kg/day in pregnant rats was approximately ...

... and embryo-fetal/postnatal survival and development. Reduction or elimination of embryo-fetal or maternal EGFR signaling can ... API MANUFACTURE(57894-501) , ANALYSIS(57894-501) Establishment. Name. Address. ID/FEI. Business Operations. ...

... and reduced pup survival. Additionally, reduced pup survival on postpartum Day 0 occurred at an exposure (mean Cmin) ... The results of the intent-to-treat analysis of the percentage of patients with a plasma HIV-1 RNA level ,400 copies/mL are ... The results of the intent‑to‑treat analysis of the percentage of patients with a plasma HIV‑1 RNA level 400 copies/mL are ... c Considered to be treatment failure in the analysis.. d Includes discontinuations due to consent withdrawn, loss to follow-up ...

survival, but the physical and behavioral development of surviving F1 pups in all groups was the. same as the deionized water ... The Coxib and traditional NSAID Trialists Collaboration meta-analysis of randomized controlled. trials demonstrated an ...