Table 1.
Characteristic⁎ | Mitochondrial toxicity-related adverse event |
|
---|---|---|
Yes (N = 23) | No (N = 15) | |
Mean age, years (SD) | 43·9 (2·0) | 35·8 (2·2) |
Male, no. (%) | 14 (60·9%) | 13 (86·7%) |
Mean body mass index (SD) | 20·6 (0·9) | 19·3 (0·9) |
Diabetes, no. (%) | 10 (43·5%) | 4 (26·7%) |
BCG vaccination, no. (%) | 16 (69·6%) | 15 (100%) |
Radiographic findings, no. (%) | ||
Far advanced | 19 (82·6%) | 10 (66·7%) |
Cavitation⁎⁎ | 10 (43·5%) | 7 (46·7%) |
Bilateral | 23 (100·0%) | 14 (93·3%) |
Median no. previous treatment episodes (IQR) | 5·0 (3·0–7·0) | 4·0 (3·0–7·0) |
Adverse event, no. (%) | ||
Peripheral neuropathy | 13 (56·5%) | |
Optic neuropathy | 6 (26·1%) | |
Myelosuppression | 4 (17·4%) |
There were no significant differences at baseline between the two groups except for age (P = 0·01) and BCG (P = 0·03). Continuous variables summarized by means were tested using a two-sample t-test, while a continuous variable summarized using a median was tested using Wilcoxon's rank sum test. Categorical variables were tested using Fisher's exact test.
Excludes 7 patients with data missing for cavitation.