Table 2.
Demographics and baseline characteristics of combined participants in Studies 001 and 002
Variable | Value (N = 240) |
---|---|
Demographics | |
Age [years] | 60 {58.4} (26–79) [0] |
Body weight [kg] | 72.8 {75.4} (46–150) [0] |
BSA [kg/m2] | 1.82 {1.84} (1.4–2.59) [0] |
Lean body mass [kg] | 49.9 {52.3} (35.7–78.9) [1] |
Height [cm] | 168 {167} (99–191) [0] |
Sex [n (%)] | |
Male | 95 (39.6%) |
Female | 145 (60.4%) |
Race [n (%)] | |
White | 224 (93.3%) |
Black | 3 (1.25%) |
Asian | 5 (2.08%) |
Other | 6 (2.5%) |
Missing | 2 (0.833%) |
Ethnicity [n (%)] | |
Hispanic/latino | 7 (2.92%) |
Not hispanic/latino | 226 (94.2%) |
Missing | 7 (2.92%) |
Lab values | |
Creatinine [µmol/L] | 66.6 {69.8} (32.7–148) [0] |
Creatinine clearance [mL/min] | 95 {100} (50–150) [0] |
Platelet count [109/L] | 274 {289} (93–816) [0] |
White cell count [cells/µL] | 7.2 {7.65} (1.37–25.2) [0] |
Albumin [g/L] | 38 {37.6} (23–49) [0] |
Bilirubin [µmol/L] | 7 {8.16} (0.5–21) [0] |
ALT [U/L] | 20 {26.9} (4–178) [0] |
AST [U/L] | 24 {31.1} (9–159) [0] |
Renal impairment [n (%)] | |
None | 137 (57.1%) |
Mild | 88 (36.7%) |
Moderate | 15 (6.25%) |
Severe | 0 (0%) |
Hepatic impairment [n (%)] | |
None | 166 (69.2%) |
Mild | 43 (17.9%) |
Moderate | 0 (0%) |
Severe | 1 (0.417%) |
Missing | 30 (12.5%) |
Disease status | |
Tumor burden [mm] | 75 {84.1} (10–312) [0] |
Tumor type [n (%)] | |
NSCLC | 48 (20.0%) |
TNBC | 33 (13.8%) |
SCLC | 16 (6.67%) |
PrCa | 7 (2.92%) |
Breast | 11 (4.58%) |
H&N | 1 (0.417%) |
CRC | 44 (18.3%) |
Ovarian | 9 (3.75%) |
Mesothelioma | 12 (5.0%) |
Other | 59 (24.6%) |
ECOG PS [n (%)] | |
0 | 65 (27.1%) |
1 | 164 (68.3%) |
2 | 5 (2.08%) |
3 | 6 (2.5%) |
Continuous covariates are reported as median {geometric mean} (range) [missing]. Categorical covariates are reported as number (percentage)
ALT alanine transaminase, AST aspartate transaminase, BSA body surface area, CRC colorectal cancer, ECOG PS Eastern Cooperative Oncology Group Performance Status, H&N head & neck, NSCLC non-small cell lung cancer, PrCa prostate cancer, SCLC small cell lung cancer, TNBC triple-negative breast cancer