Table 4 Occurrence of ADRs by patient factor.
Baseline characteristic | Number of patients in the applicable category | Number of patients with ADRs, n (%) | Odds ratio (95% CI) |
|---|---|---|---|
Safety analysis population | 76 | 50 (65.79) | - |
Sex, n (%) | |||
Male | 49 | 33 (67.35) | Reference |
Female | 27 | 17 (62.96) | 0.824 (0.308-2.203) |
Pregnancy*, n (%) | |||
No | 27 | 17 (62.96) | - |
Yes | 0 | - | |
Age category, n (%) | |||
< 15 years | 0 | - | |
≥ 15 to < 65 years | 20 | 13 (65.00) | Reference |
≥ 65 years | 56 | 37 (66.07) | 1.049 (0.359-3.065) |
Age (late elderly), n (%) | |||
< 75 years | 56 | 36 (64.29) | Reference |
≥ 75 years | 20 | 14 (70.00) | 1.296 (0.431-3.900) |
Medical history, n (%) | |||
No | 47 | 31 (65.96) | Reference |
Yes | 29 | 19 (65.52) | 0.981 (0.370-2.599) |
Comorbidity, n (%) | |||
No | 28 | 14 (50.00) | Reference |
Yes | 48 | 36 (75.00) | 3.000 (1.117-8.055) |
Comorbidity: renal impairment, n (%) | |||
No | 75 | 49 (65.33) | Reference |
Yes | 1 | 1 (100.00) | > 999.999 (< 0.001 to > 999.999) |
Comorbidity: cardiac disorders, n (%) | |||
No | 71 | 45 (63.38) | Reference |
Yes | 5 | 5 (100.00) | > 999.999 (< 0.001 to > 999.999) |
Comorbidity: others, n (%) | |||
No | 28 | 14 (50.00) | – |
Yes | 48 | 36 (75.00) | |
ECOG performance status, n (%) | |||
0-2 | 74 | 49 (66.22) | Reference |
> 3 | 2 | 1 (50.00) | 0.510 (0.031-8.503) |
Lung cancer staging classification, n (%) | |||
Stage I | 0 | - | - |
Stage II | 1 | 0 | < 0.001 (< 0.001 to > 999.999) |
Stage IIIA | 4 | 3 (75.00) | 1.610 (0.158-16.408) |
Stage IIIB | 7 | 5 (71.43) | 1.341 (0.240-7.489) |
Stage IIIC | 0 | - | - |
Stage IV | 63 | 41 (65.08) | Reference |
Unknown/not specified | 1 | 1 (100.00) | - |
Histology, n (%) | |||
Large cell carcinoma | 0 | - | - |
Squamous cell carcinoma | 1 | 1 (100.00) | > 999.999 (< 0.001 to > 999.999) |
Adenocarcinoma | 71 | 46 (64.79) | Reference |
Pleomorphic carcinoma | 1 | 1 (100.00) | > 999.999 (< 0.001 to > 999.999) |
Other | 3 | 2 (66.67) | 1.087 (0.094-12.588) |
Brain metastases, n (%) | |||
No | 63 | 41 (65.08) | Reference |
Yes | 13 | 9 (69.23) | 1.207 (0.333-4.371) |
Smoking history, n (%) | |||
Never smoked | 19 | 13 (68.42) | Reference |
Former smoker | 47 | 31 (65.96) | 0.894 (0.286-2.796) |
Current smoker | 7 | 4 (57.14) | 0.615 (0.104-3.657) |
Unknown/not specified | 3 | 2 (66.67) | – |
Number of lines of therapy used before the start of DAB/TRA treatment, n (%) | |||
0 | 24 | 16 (66.67) | Reference |
≥ 1 | 50 | 33 (66.00) | 0.971 (0.346-2.721) |
Unknown | 2 | 1 (50.00) | - |
Prior surgery for primary diagnosis, n (%) | |||
No | 53 | 38 (71.70) | Reference |
Yes | 23 | 12 (52.17) | 0.431 (0.156-1.186) |
Prior radiotherapy for primary diagnosis, n (%) | |||
No | 51 | 33 (64.71) | Reference |
Yes | 25 | 17 (68.00) | 1.159 (0.419-3.207) |
Prior treatment for primary disease, n (%) | |||
No | 24 | 16 (66.67) | Reference |
Yes | 52 | 34 (65.38) | 0.945 (0.340-2.628) |
Prior ICI treatment immediately before DAB/TRA administration, n (%) | |||
No | 61 | 39 (63.93) | Reference |
Yes | 15 | 11 (73.33) | 1.551 (0.441-5.458) |
