Table 4.
Incidence and relative risk of adverse local and systemic events present at the middle and end of treatment
| Test/event | Middle of treatment | RR (95% CI) | End of treatment | RR (95% CI) | |||
|---|---|---|---|---|---|---|---|
| Event or test/total volunteers (%) | Event or test/total volunteers (%) | ||||||
| Meglumine antimoniate | Miltefosine | Meglumine antimoniate | Miltefosine | ||||
| A Clinical symptoms | |||||||
| Clinical symptoms | Fever | 11/119 (9.2) | 8/130 (6.2) | 1.5 (0.6–3.6) | 29/131 (22.1) | 8/129 (6.2) | 3.6 (1.7–7.5)** |
| Myalgia | 12/119 (10) | 9/130 (6.9) | 1.5 (0.6–3.3) | 67/131 (51.1) | 16/129 (12.4) | 4.1 (2.5–6.7)** | |
| Arthralgia | 17/119 (14.2) | 9/130 (6.9) | 2.6 (1–4.5) | 65/131 (49.6) | 13/129 (10.1) | 4.9 (2.8–8.5)** | |
| Cephalea | 17/119 (14.2) | 23/130 (17.7) | 0.95 (0.5–1.7) | 52/131 (39.7) | 30/129 (23.3) | 1.7 (1.2–2.5)** | |
| Vomiting | 3/119 (2.5) | 29/130 (22.3) | 0.1 (0.04–0.4)** | 16/131 (12.2) | 44/129 (34,1) | 0.4 (0.2–0.6)** | |
| Nausea | 4/119 (3.4) | 38/130 (29.2) | 0.1 (0.04–0.3)** | 27/131 (20.6) | 59/129 (45.7) | 0.5 (0.3–0.7)** | |
| Anorexia | 8/119 (6.7) | 19/130 (14.6) | 0.5 (0.2–1)* | 45/131 (34.4) | 37/129 (28.7) | 1.2 (0.8–1.7) | |
| Diarrhea | – | – | – | 2/131 (1.5) | 6/129 (4.7) | 0.3 (0.1–1.6) | |
| Abdominal pain | – | – | – | 2/131 (1.5) | 9/129 (7) | 0.2 (0.05–1.0)* | |
| B Biochemistry and hematological effects | |||||||
| Blood chemistry | ↑ Creatinine | – | – | – | – | 1/103 (0.9) | – |
| ↑ BUN | 4/108 (3.7) | – | – | 1/116 (0.9) | 3/103 (2.9) | 0.3 (0.03–2.8) | |
| ↑ AST | 1/107 (0.9) | 1/113 (0.9) | 1.1 (0.07–16.8) | 10/11 1 (9) | 5/103 (4.9) | 1.9 (0.7–5.3) | |
| ↑ ALT | 3/110 (2.7) | 1/114 (0.9) | 3.1 (0.3–29.4) | 20/112 (17.9) | 10/104 (9.6) | 1.9 (0.9–3.8) | |
| ↑ Amylase | 29/105 (27.6) | 15/111 (13.5) | 2.04 (1.2–4)* | 24/109 (22) | 11/102 (10.8) | 2.04 (1.1–4)* | |
| Hematology | ↓Hemoglobin | – | – | – | 5/111 (4.5) | 1/102 (0.9) | 4.5 (0.55–38.8) |
| ↓ Erythrocytes | 14/100 (14) | 1/105 (0.9) | 14,7 (2–109.7)** | 7/107 (6.5) | 1/102 (0.9) | 6.7 (0.8–53.3) | |
| ↓ Leukocytes | 5/110 (4.5) | 2/115 (1.7) | 2.6 (0.5–13.2) | 2/115 (1.7) | 1/105 (0.9) | 1.8 (0.2–20) | |
| ↓ Platelets | 1/110 (0.9) | – | – | 1/114 (0.9) | – | – | |
*
< 0.05;
**
< 0.001.