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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