Serial No. | Adverse reaction | Frequency % (n/N) | Liposomal amphotericin B (L-AmB) mono therapy (n/N) | Miltefosine mono therapy (n/N) | Paromomycin mono therapy (n/N) | L-AmB and miltefosine combination therapy (n/N) | L-AmB and paromomycin combination therapy (n/N) | Miltefosine and paromomycin combination therapy (n/N) |
---|---|---|---|---|---|---|---|---|
1. | Fever | 16.5 (176/1066) | 20.4 (167/817) | 4.7 (9/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
2. | Vomiting | 4.8 (51/1066) | 4.2 (34/817) | 8.8 (17/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
3. | Chills | 3.9 (42/1066) | 4.9 (40/817) | 0.5 (1/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
4. | Rigor | 3.1 (33/1066) | 3.9 (32/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
5. | Nausea | 2.2 (23/1066) | 1.5 (12/817) | 5.7 (11/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
6. | Diarrhea | 1.4 (15/1066) | 1.8 (15/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
7. | Facial flushing | 1.4 (15/1066) | 1.7 (14/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
8. | Back pain | 1.2 (13/1066) | 1.5 (12/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
9. | Anorexia | 1.0 (11/1066) | 0.4 (3/817) | 4.1 (8/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
10. | Chest pain | 0.8 (9/1066) | 1.0 (8/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
11. | Abdominal pain | 0.8 (8/1066) | 0.7 (6/817) | 1.0 (2/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
12. | Headache | 0.8 (8/1066) | 0.5 (4/817) | 2.1 (4/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
13. | Death | 0.8 (8/1066) | 1.0 (8/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
14. | Heaviness of head | 0.7 (7/1066) | 0.9 (7/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
15. | Rash | 0.7 (7/1066) | 0.9 (7/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
16. | Sweating | 0.6 (6/1066) | 0.6 (5/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
17. | Malaise | 0.6 (6/1066) | 0 (0/817) | 3.1 (6/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
18. | Vertigo | 0.4 (4/1066) | 0.5 (4/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
19. | Hypotension | 0.4 (4/1066) | 0.5 (4/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
20. | Tachycardia | 0.4 (4/1066) | 0.4 (3/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
21. | Dyspnea | 0.4 (4/1066) | 0.4 (4/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
22. | Chest tightness | 0.3 (3/1066) | 0.4 (3/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
23. | Weakness | 0.3 (3/1066) | 0.4 (3/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
24. | Cough | 0.1 (1/1066) | 0 (0/817) | 0 (0/193) | 0 (0/1) | 4.2 (1/24) | 0 (0/30) | 0 (0/1) |
25. | Dyspepsia | 0.2 (2/1066) | 0.2 (2/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
26. | Hypertension | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
27. | Jaundice | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
28. | Leucopenia | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
29. | Bone pain | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
30. | Arthralgia | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
31. | Allergic reaction | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
32. | Belching | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
33. | Injection site swelling | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
34. | Lymphadenopathy | 0.1 (1/1066) | 1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
35. | Salivation | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
36. | Respiratory insufficiency | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
37. | Pruritus | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
38. | Leucopenia | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
39. | Annular corneal ulcer | 0.1 (1/1066) | 0 (0/817) | 0.5 (1/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
40. | Mooren’s ulcer | 0.1 (1/1066) | 0 (0/817) | 0.5 (1/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
41. | Avascular necrosis of alae of nose | 0.1 (1/1066) | 0.1 (1/817) | 0 (0/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |
42. | Cervical lymphonode | 0.1 (1/1066) | 0 (0/817) | 0.5 (1/193) | 0 (0/1) | 0 (0/24) | 0 (0/30) | 0 (0/1) |