TABLE 1.
Baseline demographics and clinical variables for patients in the correction factor analysis (n = 1,686) and the comparison of QTc by treatment arm (n = 1,602)
| Demographic characteristic or clinical variable | Correction factor analysis (n = 1,686) |
Between-arm comparison (n = 1,602) |
||
|---|---|---|---|---|
| Test (n = 845) | Control (n = 841) | Test (n = 804) | Control (n = 798) | |
| No. of patients from country (%) | ||||
| Benin | 158 (18.7) | 158 (18.8) | 150 (18.7) | 151 (18.9) |
| Guinea | 219 (25.9) | 225 (26.7) | 216 (26.9) | 213 (26.7) |
| Kenya | 100 (11.8) | 97 (11.5) | 100 (12.4) | 95 (11.9) |
| Senegal | 178 (21.1) | 180 (21.4) | 154 (19.1) | 163 (20.4) |
| South Africa | 190 (22.5) | 181 (21.5) | 184 (22.9) | 176 (22.1) |
| Mean age, yr (SD) | 30.8a (9.1) | 30.6 (9.0) | 30.8 (9.1) | 30.6 (8.9) |
| No. female (%) | 229 (27.1) | 232 (27.6) | 215 (26.7) | 224 (28.1) |
| No. HIV positive (%)b | 147 (17.5) | 156 (18.8) | 141 (17.6) | 150 (18.9) |
| No. with cavitation (%)c | 438 (52.0) | 417 (50.0) | 413 (51.5) | 394 (49.8) |
| Mean heart rate (SD)d | 95.6 (17.4) | 95.1 (17.8) | 95.6 (17.5) | 95.2 (17.5) |
| No. with temp >37.7°C (%)e | 216 (25.6) | 198 (23.6) | 201 (25.0) | 187 (23.5) |
| Mean BMI (SD)f | 17.4 (4.9) | 17.5 (5.0) | 17.3 (4.9) | 17.5 (5.0) |
Age not known for n = 1 in the test arm.
HIV status unknown in the correction factor analysis for n = 11 (n = 5 in the test arm, n = 6 in the control arm) and in the between-arm comparison for n = 10 (n = 5 in the test arm, n = 5 in the control arm).
Cavitary status unknown in the correction factor analysis for n = 10 (n = 3 in the test arm, n = 7 in the control arm) and in the between-arm comparison for n = 9 (n = 2 in the test arm, n = 7 in the control arm).
Heart rate unknown in the between-arm comparison for n = 4 (n = 2 in the test arm, n = 2 in the control arm).
Temperature unknown in the correction factor analysis for n = 4 (n = 1 in the test arm, n = 3 in the control arm) and in the between-arm comparison for n = 3 (n = 1 in the test arm, n = 2 in the control arm).
BMI, body mass index.