Table 3.
Patients’ demographic and baseline characteristics by analysis set and treatment group
| Demographic characteristics | ITT, mITT and safety population | PP population | |||||||
|---|---|---|---|---|---|---|---|---|---|
| NECT (n = 55) | Eflornithine (n = 54) | All (n = 109) | P-value | NECT (n = 53) | Eflornithine (n = 52) | All (n = 105) | P-value | ||
| Age (years) | Mean (SD) | 27.22 (12.07) | 27.33 (8.59) | 27.28 (10.44) | 0.3804c | 27.49 (12.18) | 27.38 (8.60) | 27.44 (10.51) | 0.4644c |
| Sex | Male, n (%) | 29 (52.73) | 28 (51.85) | 57 (52.29) | 0.9271a | 28 (52.83) | 26 (50.00) | 54 (51.43) | 0.7717a |
| Female, n (%) | 26 (47.27) | 26 (48.15) | 52 (47.71) | – | 25 (47.17) | 26 (50.00) | 51 (48.57) | – | |
| Height (cm) | Mean (SD) | 162.6 (10.38) | 165.2 (9.52) | 163.9 (10.00) | 0.1843b | 162.8 (10.25) | 165.1 (9.60) | 164.0 (9.96) | 0.2334b |
| Screening mode | Active, n (%) | 19 (34.55) | 18 (33.33) | 37 (33.94) | – | 19 (35.85) | 17 (32.69) | 36 (34.29) | 0.7333a |
| Passive, n (%) | 36 (65.45) | 36 (66.67) | 72 (66.06) | – | 34 (64.15) | 35 (67.31) | 69 (65.71) | – | |
| Weight (kg) | Mean (SD) | 49.25 (10.04) | 54.18 (8.82) | 51.69 (9.73) | 0.0076b | 49.58 (9.87) | 54.08 (8.94) | 51.80 (9.65) | 0.0161b |
| BMI (kg/m2) | Mean (SD) | 18.42 (2.23) | 19.81 (2.58) | 19.11 (2.50) | 0.0034b | 18.52 (2.18) | 19.79 (2.63) | 19.15 (2.48) | 0.0086b |
| Blood pressure systolic (mmHg) | Mean (SD) | 112.3 (13.97) | 112.2 (14.32) | 112.3 (14.08) | 0.7618c | 112.8 (14.03) | 111.6 (14.21) | 112.2 (14.06) | 0.4247c |
| Blood pressure diastolic (mmHg) | Mean (SD) | 72.22 (10.10) | 73.50 (10.54) | 72.85 (10.30) | 0.5183b | 72.40 (10.23) | 72.92 (10.31) | 72.66 (10.22) | 0.8574c |
| Heart rate (/min) | Mean (SD) | 82.82 (14.17) | 82.19 (13.62) | 82.50 (13.84) | 0.8126b | 82.57 (14.32) | 82.69 (13.46) | 82.63 (13.83) | 0.9630b |
| Respiratory rate (/min) | Mean (SD) | 20.58 (2.94) | 20.69 (3.70) | 20.63 (3.32) | 0.7350c | 20.49 (2.90) | 20.85 (3.67) | 20.67 (3.29) | 0.9222c |
| Body temperature (°C) | Mean (SD) | 36.53 (0.53) | 36.71 (0.71) | 36.62 (0.63) | 0.1349b | 36.54 (0.54) | 36.73 (0.71) | 36.63 (0.63) | 0.1204b |
| Glasgow Coma score | Mean (SD) | 14.77 (0.50) | 14.83 (0.38) | 14.80 (0.44) | 0.8000c | 14.77 (0.50) | 14.82 (0.39) | 14.79 (0.45) | 0.8014c |
| Karnofsky index (%) | Mean (SD) | 79.64 (9.62) | 82.04 (7.62) | 80.83 (8.73) | 0.2976c | 79.62 (9.80) | 81.73 (7.60) | 80.67 (8.80) | 0.4659c |
Abbreviations: DFMO eflornithine, ITT intent to treat population, mITT modified ITT population, PP per-protocol population
aChi-square test
bStudent’s t-test (pooled)
cWilcoxon-Mann-Whitney test