Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma
Brief Summary: This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.


Options:
A: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))
B: Overall Survival (OS) (Overall median duration of follow-up was 15.5 months (range: 0.1, 35.6).)
C: Adult Study: Overall Survival (OS) (From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.); Adult Study: Progression-Free Survival (PFS) (Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years); Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug (From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks); Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Half-life (t1/2) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8)
D: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)

Answer: D