Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-Based Cohorts (LEANORA)

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Anthropometry (1)

WEIGHT_BASE - Subject's weight at baseline (phv00544047.v1.p1)

Biomarkers (24)

ALBUMIN_BASE - Albumin at baseline (phv00544057.v1.p1)
ALBUMIN_END - Albumin end-cycle 1 (phv00544059.v1.p1)
ALBUMIN_MID - Albumin mid-cycle 1 (phv00544058.v1.p1)
ALT_BASE - Alanine transaminase prior to cycle 1 (phv00544040.v1.p1)
ALT_END - Alanine transaminase end-cycle 1 (phv00544042.v1.p1)
ALT_MID - Alanine transaminase mid-cycle 1 (phv00544041.v1.p1)
ANC_BASE - Absolute neutrophil count at baseline (phv00544063.v1.p1)
ANC_END - Absolute neutrophil count end-cycle 1 (phv00544065.v1.p1)
ANC_MID - Absolute neutrophil count mid-cycle 1 (phv00544064.v1.p1)
AST_BASE - Aspartate transferase prior to cycle 1 (phv00544037.v1.p1)
AST_END - Aspartate transferase end-cycle 1 (phv00544039.v1.p1)
AST_MID - Aspartate transferase mid-cycle 1 (phv00544038.v1.p1)
CRCL_BASELINE - Creatinine clearance at baseline (phv00544043.v1.p1)
CRCL_END - Creatinine clearance end-cycle 1 (phv00544045.v1.p1)
CRCL_MIDCYCLE - Creatinine clearance mid-cycle 1 (phv00544044.v1.p1)
HB_BASE - Hemoglobin at baseline (phv00544066.v1.p1)
HB_END - Hemoglobin end-cycle 1 (phv00544068.v1.p1)
HB_MID - Hemoglobin mid-cycle 1 (phv00544067.v1.p1)
PLATELETS_BASE - Platelets at baseline (phv00544069.v1.p1)
PLATELETS_END - Platelets end-cycle 1 (phv00544071.v1.p1)
PLATELETS_MID - Platelets mid-cycle 1 (phv00544070.v1.p1)
WBC_BASE - White blood cells per microliter at baseline (phv00544060.v1.p1)
WBC_END - White blood cells per microliter end-cycle 1 (phv00544062.v1.p1)
WBC_MID - White blood cells per microliter mid-cycle 1 (phv00544061.v1.p1)

Demographics (2)

AGE - Subject age at enrollment (phv00544046.v1.p1)
SEX - Biological sex (phv00544022.v1.p1)

Race and Ethnicity (1)

RACE - Self-reported race (phv00544026.v1.p1)

Substance Use (1)

SMOKING - Smoking status (phv00544051.v1.p1)

Other (32)

ANALYTE_TYPE - Analyte Type (phv00544077.v1.p1)
ANY_AE - Any adverse event in cycle 1 (phv00544033.v1.p1)
ANY_GRADE3PLUS_AE - Any >grade 2 adverse event in cycle 1 (phv00544034.v1.p1)
AUC0_6 - Area under the curve between 0 and 6 hours (phv00544030.v1.p1)
AUCTAU - AUC over the dosing interval (phv00544032.v1.p1)
Body Surface Area - Body surface area (phv00544048.v1.p1)
BODY_SITE - Body site where sample was collected (phv00544076.v1.p1)
C_6H - Plasma concentration at 6 hours (phv00544031.v1.p1)
CMAX - Maximum plasma concentration (phv00544028.v1.p1)
COLLECTION_AGE - Age sample was collected (phv00544080.v1.p1)
CONSENT - Consent group as determined by DAC (phv00544021.v1.p1)
ECOG - Eastern Cooperative Oncology Group performance status scale (phv00544049.v1.p1)
FULVESTRANT - Received fulvestrant (phv00544035.v1.p1)
HISTOLOGICAL_TYPE - Cell or tissue type or subtype of sample (phv00544079.v1.p1)
IS_TUMOR - Tumor status (phv00544078.v1.p1)
NOT_RECOMMENDED_MED_N - Number of medications taken that were not recommended by the protocol (phv00544073.v1.p1)
OFS - Received ovarian function suppression (phv00544036.v1.p1)
PK_DAY - PK collection day after beginning of cycle 1 (phv00544027.v1.p1)
PROHIB_OR_NOTREC_N - Number of medications taken that were either prohibited or not recommended by the protocol (phv00544074.v1.p1)
PROHIBITED_MED_N - Number of medications taken that were prohibited by the protocol (phv00544072.v1.p1)
QTC_BASE - QTc at baseline (phv00544053.v1.p1)
QTC_CTCAE_CONSENSUS - CTCAE classification of QT prolongation (phv00544056.v1.p1)
QTC_END - QTc end-cycle 1 (phv00544055.v1.p1)
QTC_MID - QTc mid-cycle 1 (phv00544054.v1.p1)
RIBO_DAYS_PRIORTOPK - Days received ribociclib prior to PK analysis (phv00544050.v1.p1)
SAMPLE_ID - Sample ID (phv00544075.v1.p1)
SAMPLE_ID - Sample ID (phv00544024.v1.p1)
STAGE - Breast cancer stage (phv00544052.v1.p1)
SUBJECT_ID - Subject ID (phv00544025.v1.p1)
SUBJECT_ID - Subject ID (phv00544020.v1.p1)
SUBJECT_ID - Subject ID (phv00544023.v1.p1)
TMAX - Time to maximum plasma concentration (phv00544029.v1.p1)