Skip to main content

Table 2 Adverse events

From: Optimal regimens of sulfamethoxazole-trimethoprim for chemoprophylaxis of Pneumocystis pneumonia in patients with systemic rheumatic diseases: results from a non-blinded, randomized controlled trial

  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
  1. 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