| 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 |