Table 8. Incidence of adverse drug reactions.*.
| AmBisome + SSG | AmBisome + Miltefosine | Miltefosine | |||||||
|---|---|---|---|---|---|---|---|---|---|
| <12 years | ≥12 years | Total | <12 years | ≥12 years | Total | <12 years | ≥12 years | Total | |
| 23 | 28 | 51 | 24 | 25 | 49 | 20 | 31 | 51 | |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS | |||||||||
| ANAEMIA | 2 (9%) | 1 (4%) | 3 (6%) | 4 (17%) | 0 (0%) | 4 (8%) | 5 (25%) | 1 (3%) | 6 (12%) |
| GASTROINTESTINAL DISORDERS | |||||||||
| VOMITING | 0 (0%) | 1 (4%) | 1 (2%) | 8 (33%) | 3 (12%) | 11 (22%) | 6 (30%) | 7 (23%) | 13 (25%) |
| GENERAL DISORDERS AND ADMINISTRATION | |||||||||
| PYREXIA | 8 (35%) | 3 (11%) | 11 (22%) | 3 (13%) | 2 (8%) | 5 (10%) | 3 (15%) | 1 (3%) | 4 (8%) |
| INVESTIGATIONS | |||||||||
| ALANINE AMINOTRANSFERASE INCREASED | 3 (13%) | 2 (7%) | 5 (10%) | 1 (4%) | 2 (8%) | 3 (6%) | 4 (20%) | 5 (16%) | 9 (18%) |
| ASPARTATE AMINOTRANSFERASE INCREASED | 6 (26%) | 5 (18%) | 11 (22%) | 5 (21%) | 2 (8%) | 7 (14%) | 6 (30%) | 9 (29%) | 15 (29%) |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 4 (17%) | 3 (11%) | 7 (14%) | 4 (17%) | 0 (0%) | 4 (8%) | 3 (15%) | 2 (6%) | 5 (10%) |
| BLOOD CREATININE INCREASED | 1 (4%) | 4 (14%) | 5 (10%) | 1 (4%) | 3 (12%) | 4 (8%) | 1 (5%) | 2 (6%) | 3 (6%) |
| BLOOD UREA INCREASED | 4 (17%) | 1 (4%) | 5 (10%) | 3 (13%) | 3 (12%) | 6 (12%) | 1 (5%) | 1 (3%) | 2 (4%) |
| METABOLISM AND NUTRITION DISORDERS | |||||||||
| HYPOKALAEMIA | 1 (4%) | 5 (18%) | 6 (12%) | 2 (8%) | 3 (12%) | 5 (10%) | 0 (0%) | 0 (0%) | 0 (0%) |
| HYPOMAGNESAEMIA | 4 (17%) | 3 (11%) | 7 (14%) | 7 (29%) | 0 (0%) | 7 (14%) | 5 (25%) | 5 (16%) | 10 (20%) |
| HYPONATRAEMIA | 2 (9%) | 1 (4%) | 3 (6%) | 3 (13%) | 2 (8%) | 5 (10%) | 3 (15%) | 0 (0%) | 3 (6%) |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | |||||||||
| EPISTAXIS | 5 (22%) | 0 (0%) | 5 (10%) | 1 (4%) | 1 (4%) | 2 (4%) | 2 (10%) | 2 (6%) | 4 (8%) |
| CARDIAC DISORDERS | |||||||||
| ARRYTHMIA SUPRAVENTRICULAR | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) |
| SINUS ARRYTHMIA | 1 (4%) | 1 (4%) | 2 (4%) | 3 (13%) | 0 (0%) | 3 (6%) | 0 (0%) | 0 (0%) | 0 (0%) |
| SINUS BRADYCARDIA | 0 (0%) | 1 (4%) | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| INVESTIGATIONS | |||||||||
| ELECTROCARDIOGRAM ABNORMAL | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 0 (0%) | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) |
| RENAL AND URINARY DISORDERS | |||||||||
| RENAL IMPAIRMENT | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 0 (0%) | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) |
| RENAL FAILURE | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) |
* All events which occurred with more than 5% overall frequency, together with all cardiac disorders, and renal disorders.
Note: Causality assessment was based on investigator judgment. According to protocol all events that were not recorded as ‘Not Related’ were considered ‘Adverse Drug Reactions’