Table 2.
Adverse events
| SS (n = 58) |
HS (n = 59) |
ES (n = 55) |
P value | |
|---|---|---|---|---|
| AE, n (%) (95% CI) | 32 (55.2) (41.5–68.3) |
24 (40.7) (28.1–54.3) |
26 (47.3) (33.7–61.2) |
0.300 |
| Serious AEa, n (%) (95% CI) | 9 (15.5) (7.3–27.4) |
11 (18.6) (9.7–30.9) |
6 (10.9) (4.1–22.2) |
0.534 |
| AE required dose reduction of SMX/TMP, n (%), (95% CI) | 11 (19.0) (9.9–31.4) |
2 (3.4)* (0.4–11.7) |
3 (5.5)* (1.1–15.1) |
0.009 |
| AE required discontinuation of SMX/TMP, n (%), (95% CI) | 12 (20.7) (11.2–33.4) |
5 (8.5) (2.8–18.7) |
5 (9.1) (3.0–20.0) |
0.110 |
| AE leading to death, n (%), (95% CI) | 1 (1.7) (0–9.2) |
3 (5.1) (1.1–14.1) |
1 (1.8) (0–9.7) |
0.622 |
| AE of special interest, n (%), (95% CI) | 26 (44.8) (31.7–58.5) |
12 (20.3)* (11.0–32.8) |
10 (18.2)* (9.1–30.9) |
0.003 |
| Fever, n (%) | 2 (3.4) | 0 (0.0) | 0 (0.0) | ND |
| Rash, n (%) | 5 (8.6) | 2 (3.4) | 1 (1.8) | ND |
| Appetite loss, n (%) | 1 (1.7) | 0 (0.0) | 1 (1.8) | ND |
| Anemia, n (%) | 1 (1.7) | 1 (1.7) | 0 (0.0) | ND |
| Leukocytopenia, n (%) | 1 (1.7) | 1 (1.7) | 0 (0.0) | ND |
| Thrombocytopenia, n (%) | 9 (15.5) | 4 (6.8) | 5 (9.1) | ND |
| Elevated LFT, n (%) | 7 (12.1) | 6 (10.2) | 4 (7.3) | ND |
| Elevated serum creatinine, n (%) | 3 (5.2) | 1 (1.7) | 1 (1.8) | ND |
| Hyponatremia, n (%) | 5 (8.6) | 1 (1.7) | 0 (0.0) | ND |
| Hyperpotassemia, n (%) | 3 (5.2) | 3 (5.1) | 1 (1.8) | ND |
aSerious adverse events (AE): sepsis, organizing pneumonia, severe liver failure, flare of rheumatic disease, rash that required hospitalization, thrombocytopenia that required hospitalization, mental disorder that required hospitalization, and death. SS the single-strength dosage group, HS the half-strength dosage group, ES the escalation dosage group, AE adverse events, SMX/TMP sulfamethoxazole-trimethoprim, LFT liver function test, ND not done. *p < 0.05 by adjusted residuals vs. SS