Table 2.
Baseline assessments of clinical signs and symptoms of CABP
| Sign/symptom present at baseline | ITT population |
CE population |
||
|---|---|---|---|---|
| Solithromycin 800/400 mg (N = 65) | Levofloxacin 750 mg (N = 67) | Solithromycin 800/400 mg (N = 55) | Levofloxacin 750 mg (N = 58) | |
| Patients with ≥3 signs/symptoms of CABPa [n (%)]b | 65 (100.0) | 66 (98.5) | 55 (100.0) | 57 (98.3) |
| Feverc [n (%)] | 26 (40.0) | 30 (44.8) | 21 (38.2) | 27 (46.6) |
| Abnormal WBCd [n (%)] | 185 (27.7) | 21 (31.3) | 15 (27.3) | 19 (32.8) |
| Cough [n (%)] | ||||
| Mild | 3 (4.6) | 12 (17.9) | 3 (5.5) | 10 (17.2) |
| Moderate | 33 (50.8) | 35 (52.2) | 27 (49.1) | 28 (48.3) |
| Severe | 28 (43.1) | 20 (29.9) | 24 (43.6) | 20 (34.5) |
| Dyspnea [n (%)] | ||||
| Mild | 16 (24.6) | 20 (29.9) | 11 (20.0) | 17 (29.3) |
| Moderate | 40 (61.5) | 33 (49.3) | 36 (65.5) | 30 (51.7) |
| Severe | 6 (9.2) | 5 (7.5) | 5 (9.1) | 3 (5.2) |
| Chest pain due to pneumonia [n (%)] | ||||
| Mild | 16 (24.6) | 13 (19.4) | 12 (21.8) | 10 (17.2) |
| Moderate | 19 (29.2) | 27 (40.3) | 16 (29.1) | 23 (39.7) |
| Severe | 14 (21.5) | 16 (23.9) | 12 (21.8) | 16 (27.6) |
| Sputum production [n (%)] | ||||
| Mild | 20 (30.8) | 22 (32.8) | 19 (34.5) | 19 (32.8) |
| Moderate | 25 (38.5) | 30 (44.8) | 20 (36.4) | 24 (41.4) |
| Severe | 14 (21.5) | 10 (14.9) | 11 (20.0) | 10 (17.2) |
a
≥3 of the following: cough with sputum production; dyspnea or tachypnea; chest pain due to pneumonia; fever; rales, rhonchi, dullness on percussion, bronchial breath sounds, wheezing, or egophony; abnormal white blood cell (WBC) count.
b
n, number of patients with sign/symptom; N, number of patients with an assessment of the specified sign or symptom at baseline; %, 100 × (n/N).
c
Temperature of >38°C (100.4°F), tympanic of >38.5°C (101.2°F), axillary of >38.1°C (100.6°F), or rectal/core of >39°C (102.2°F).
d
WBC count of <3,000 cells/mm3 or >11,000 cells/mm3.