Table 1 Demographic and disease characteristics of patients in the safety analysis set.
Baseline characteristic | Safety analysis set (N = 76) |
|---|---|
Sex, n (%) | |
Male | 49 (64.47) |
Female | 27 (35.53) |
Age (years) | |
Mean (SD) | 68.0 (10.2) |
Median | 68.5 |
Min-Max | 31-87 |
Age category, n (%) | |
< 15 years | 0 |
≥ 15 to < 65 years | 20 (26.32) |
≥ 65 years | 56 (73.68) |
Age (late elderly), n (%) | |
< 75 years | 56 (73.68) |
≥ 75years | 20 (26.32) |
Duration of diseases (weeks) | n = 73 |
Mean (SD) | 114.3 (153.0) |
Median | 51.0 |
Min-Max | 0-748 |
Medical history, n (%) | |
No | 47 (61.84) |
Yes | 29 (38.16) |
Comorbidity, n (%) | |
No | 28 (36.84) |
Yes | 48 (63.16) |
Comorbidity: Hepatic impairment, n (%) | |
No | 76 (100.00) |
Yes | 0 |
Comorbidity: renal impairment, n (%) | |
No | 75 (98.68) |
Yes | 1 (1.32) |
Comorbidity: cardiac disorders, n (%) | |
No | 71 (93.42) |
Yes | 5 (6.58) |
Comorbidity: others, n (%) | |
No | 28 (36.84) |
Yes | 48 (63.16) |
ECOG performance status, n (%) | |
0 | 24 (31.58) |
1 | 41 (53.95) |
2 | 9 (11.84) |
3 | 2 (2.63) |
4 | 0 |
Lung cancer staging classification, n (%) | |
Stage IA | 0 |
Stage IB | 0 |
Stage IIA | 1 (1.32) |
Stage IIB | 0 |
Stage IIIA | 4 (5.26) |
Stage IIIB | 7 (9.21) |
Stage IIIC | 0 |
Stage IVA | 26 (34.21) |
Stage IVB | 37 (48.68) |
Unknown/not specified | 1 (1.32) |
Histology, n (%) | |
Large cell carcinoma | 0 |
Squamous cell carcinoma | 1 (1.32) |
Adenocarcinoma | 71 (93.42) |
Pleomorphic carcinoma | 1 (1.32) |
Other | 3 (3.95) |
Brain metastases, n (%) | |
No | 63 (82.89) |
Yes | 13 (17.11) |
Smoking history, n (%) | |
Never smoked | 19 (25.00) |
Former smoker | 47 (61.84) |
Current smoker | 7 (9.21) |
Unknown | 3 (3.95) |
Number of lines of therapy used before the start of treatment with DAB/TRA, n (%) | |
0 | 24 (31.58) |
1 | 20 (26.32) |
2 | 8 (10.53) |
3 | 10 (13.16) |
4 | 12 (15.79) |
Unknown | 2 (2.63) |
Prior surgery for primary diagnosis, n (%) | |
No | 53 (69.74) |
Yes | 23 (30.26) |
Prior radiotherapy for primary diagnosis, n (%) | |
No | 51 (67.11) |
Yes | 25 (32.89) |
Prior treatment for primary disease, n (%) | |
No | 24 (31.58) |
Yes | 52 (68.42) |
Prior ICI medication immediately before DAB/TRA administration, n (%) | |
No | 61 (80.26) |
Yes | 15 (19.74) |
