--- a +++ b/clusters/9knumclustersv2/clust_1175.txt @@ -0,0 +1,148 @@ +Must be obtained within days prior to registration for protocol therapy: Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Direct bilirubin ? . ULN (may be assumed if total bilirubin is below ULN) +Bilirubin =< . x ULN OR direct bilirubin of =< ULN for subjects with total bilirubin levels of > . x ULN obtained within days prior to registration +Total bilirubin =< . x ULN OR, for subjected with total bilirubin levels > . x ULN, a direct bilirubin =< ULN must be met within days of CD +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +SAFETY RUN-IN: Within days of registration: Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +RANDOMIZED PHASE II CLINICAL TRIAL: Within days of registration: Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin and direct bilirubin =< ULN +Total bilirubin ? . x ULN or direct bilirubin ? ULN for subjects with total bilirubin > . x ULN +Total bilirubin =< . x ULN OR direct bilirubin =< x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > . ULN. +Within days of treatment registration: Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin ? . ULN or direct bilirubin ? ULN. +At time of registration and within weeks prior to initiating on-protocol treatment: Total bilirubin =< . x ULN, OR direct bilirubin =< ULN for participants with total bilirubin levels >. x ULN +Within days prior to the start of study treatment: Total bilirubin =< . X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > . x ULN +STRATUM A: Total bilirubin =< ULN or if > ULN then direct bilirubin =< . x ULN +STRATUM B: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< . x ULN +STRATUM C: Total bilirubin =< ULN; or if > ULN then direct bilirubin =< . x ULN +Serum total bilirubin =< . times upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin >= . x ULN +Within days of cycle day : Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Within days prior to the start of study treatment: Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN. +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN. +Within days of registration: Total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN +Obtained =< days prior to registration: Serum total bilirubin =< . X upper limit of normal (ULN) or direct bilirubin =< (ULN) for subjects with total bilirubin levels > . ULN +Within days prior to enrollment: Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > . ULN +Total bilirubin ? . upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin ? . X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Obtained =< days prior to registration: Total bilirubin =< . x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > . x ULN +Total bilirubin ?. times the ULN, or direct bilirubin <ULN for patients with total bilirubin levels >.xULN; +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin >= . x ULN OR direct bilirubin >= ULN for patients with total bilirubin levels > . x ULN +Serum total bilirubin =< . x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Within days prior to registration for protocol therapy: Serum total bilirubin => . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN; unless due to Gilberts disease or hemolysis +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN, during screening and on cycle , day +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin: =< . X ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > . ULN +Total serum bilirubin =< . x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > . x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN within days prior to registration +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin < . mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > . X ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Performed days prior to study registration up to the first dose of study drug: serum total bilirubin =< . X ULN (except for subjects with Gilbert syndrome, who may have total bilirubin < . mg/dl) or direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin levels =< . x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin ? . x ULN for age, direct bilirubin ? ULN for age +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN (patients who do not meet this criteria must have a direct\r\nbilirubin =< . X ULN) +Direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Direct bilirubin ? ULN for subjects with total bilirubin levels > . x ULN +Performed within days prior to study registration up to the first dose of study drug: Serum total bilirubin =< . X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for patients with total bilirubin level . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > . x ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for patients with total bilirubin levels > . x ULN +Serum total bilirubin ? . X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin ? . x ULN OR o Direct bilirubin ? ULN for subjects with total bilirubin >. x ULN +Total bilirubin (<=) * ULN or direct bilirubin level (<=) .* ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X upper limit of normal (ULN) or direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin ? . X ULN OR direct bilirubin ? ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +REGISTRATION TO TREATMENT (STEP ): Serum total bilirubin =< . X ULN OR direct bilirubin \r\n=< ULN for subjects with total bilirubin levels > . X ULN, within days prior to first dose of pembrolizumab +REGISTRATION TO TREATMENT (STEP ): Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . X ULN, within days prior to first dose of pembrolizumab +Total bilirubin ? . ULN OR direct bilirubin ? ULN if total bilirubin > . x ULN +Serum total bilirubin ? . X ULN OR direct bilirubin ? ULN for patients with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x upper limit of normal (ULN) OR direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN obtained =< days prior to registration +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Direct bilirubin: =< ULN for patients with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN; patients with Gilberts syndrome must have a total bilirubin < . mg/dL +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin =< . x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > . x ULN, specimens must be collected within days prior to the start of study treatment +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total Bilirubin: ?.xULN OR Direct bilirubin ?ULN for subjects with total bilirubin levels >.xULN +Total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x upper limit of normal (ULN) OR direct bilirubin =< ULN if total bilirubin levels > . x ULN (within days prior to day of protocol therapy) +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Within weeks of administration of study therapy: Serum total bilirubin =< . x ULN or direct bilirubin =< ULN for patients with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +total bilirubin ? . upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN, performed within days prior to registration +Performed within days of radiation therapy: Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . x ULN (direct bilirubin =< ULN if total bilirubin [bili] > . x ULN) +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin >= . ULN +Total bilirubin levels < . X ULN +Serum total bilirubin =< . x ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > . x ULN +Total bilirubin ? . upper limit of normal (ULN) OR direct bilirubin ? ULN for subjects with total bilirubin levels > . x ULN +Serum total bilirubin =< . x ULN (. mg/dL or . umol/L) OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN; except patients with Gilbert's disease (=< x ULN) +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin ? .x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ? ULN for age. +Bilirubin and total bilirubin levels =< . x ULN +Total bilirubin ? . ULN OR direct bilirubin ? ULN +Bilirubin levels < . x ULN +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Direct serum bilirubin ? . x ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN, obtained =< days prior to registration +Serum total bilirubin =< . x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN +Serum total bilirubin =< . X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > . ULN, performed within days of protocol enrollment