TABLE 3.
Baseline clinical characteristicsa
| Clinical characteristic | No. (%) of patients
|
|||
|---|---|---|---|---|
| ITT population
|
Clinical PP population
|
|||
| 2,000/125 mg (n = 322) | 875/125 mg (n = 311) | 2,000/125 mg (n = 247) | 875/125 mg (n = 226) | |
| Fever or history of fever | 321 (99.7) | 310 (99.7) | 247 (100) | 226 (100) |
| Altered total white blood cell count | 134 (41.6) | 127 (40.8) | 91 (36.8) | 89 (39.4) |
| Sputum | ||||
| Purulent | 290 (90.1) | 278 (89.4) | 221 (89.5) | 203 (89.8) |
| Change in characteristics | 217 (67.4) | 201 (64.6) | 159 (64.4) | 146 (64.6) |
| New or increased cough | 319 (99.1) | 311 (100) | 244 (98.8) | 226 (100) |
| Signs of pneumonia | ||||
| Cough | 319 (99.1) | 311 (100) | 244 (98.8) | 226 (100) |
| Dyspnea | 233 (72.4) | 233 (74.9) | 173 (70.0) | 168 (74.3) |
| Tachypnea | 190 (59.0) | 186 (59.8) | 142 (57.5) | 133 (58.8) |
| Hypoxemia | 48 (14.9) | 43 (13.8) | 36 (14.6) | 31 (13.7) |
| Pleuritic chest pain | 215 (66.8) | 234 (75.2) | 160 (64.8) | 169 (74.8) |
| Auscultatory finding | ||||
| Rales | 271 (84.2) | 265 (85.2) | 205 (83.0) | 191 (84.5) |
| Pulmonary consolidation | 181 (56.2) | 169 (54.3) | 131 (53.0) | 116 (51.3) |
| Chest X-ray consistent with pneumonia | 308 (95.7) | 296 (95.2) | 247 (100) | 226 (100) |
| Preexisting COPD at screening | 54 (16.8) | 49 (15.8) | 36 (14.6) | 40 (17.7) |
| In-patient at screening | 75 (23.3) | 69 (22.2) | 58 (23.5) | 47 (20.8) |
| Mortality risk class for inpatients | ||||
| Low | ||||
| Class I (% of inpatients) | 23 (30.7) | 21 (30.4) | 21 (36.2) | 17 (36.2) |
| Class II (% of inpatients) | 15 (20.0) | 19 (27.5) | 10 (17.2) | 10 (21.3) |
| Class III (% of inpatients) | 20 (26.7) | 15 (21.7) | 18 (31.0) | 11 (23.4) |
| Moderate | ||||
| Class IV (% of inpatients) | 15 (20.0) | 10 (14.5) | 8 (13.8) | 8 (17.0) |
| High | ||||
| Class V (% of inpatients) | 2 (2.7) | 4 (5.8) | 1 (1.7) | 1 (2.1) |
a
ITT, intent to treat; PP, per protocol; COPD, chronic obstructive pulmonary disease.