Table 4.
Summary of Treatment-Emergent Adverse Drug Reactions by Treatment Arm: by System Organ Class and Preferred Term—Modified Intention-to-Treat Set
| Treatment Arm | |||||
|---|---|---|---|---|---|
| PM/MF (14 Days) | PM/MF (28 Days)a | SSG/PM | Total | ||
| System Organ Class | Preferred Term | n = 170 | n = 98 | n = 170 | n = 438 |
| Any treatment-emergent adverse drug reaction | … | 59 (34.7) [108] | 44 (44.9) [77] | 31 (18.2) [46] | 134 (30.6) [231] |
| Blood and lymphatic system disorders | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.6) [1] | 1 (0.2) [1] | |
| Neutropenia | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.6) [1] | 1 (0.2) [1] | |
| Cardiac disorders | … | 0 (0.0) [0] | 0 (0.0) [0] | 4 (2.4) [4] | 4 (0.9) [4] |
| Arrhythmia | 0 (0.0) [0] | 0 (0.0) [0] | 3 (1.8) [3] | 3 (0.7) [3] | |
| Sinus arrhythmia | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.6) [1] | 1 (0.2) [1] | |
| Ear and labyrinth disorders | … | 9 (5.3) [15] | 11 (11.2) [17] | 3 (1.8) [4] | 23 (5.3) [36] |
| Hypoacusis | 8 (4.7) [14] | 11 (11.2) [17] | 3 (1.8) [4] | 22 (5.0) [35] | |
| Deafness bilateral | 1 (0.6) [1] | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Gastrointestinal disorders | … | 40 (23.5) [59] | 26 (26.5) [37] | 1 (0.6) [1] | 67 (15.3) [97] |
| Vomiting | 34 (20.0) [48] | 25 (25.5) [35] | 0 (0.0) [0] | 59 (13.5) [83] | |
| Gastritis | 4 (2.4) [4] | 1 (1.0) [1] | 0 (0.0) [0] | 5 (1.1) [5] | |
| Abdominal pain | 2 (1.2) [2] | 1 (1.0) [1] | 0 (0.0) [0] | 3 (0.7) [3] | |
| Dyspepsia | 2 (1.2) [2] | 0 (0.0) [0] | 0 (0.0) [0] | 2 (0.5) [2] | |
| Nausea | 1 (0.6) [1] | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Abdominal pain upper | 1 (0.6) [1] | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Gastrointestinal inflammation | 1 (0.6) [1] | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Pancreatitis | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.6) [1] | 1 (0.2) [1] | |
| General disorders and administration site conditions | … | 17 (10.0) [17] | 14 (14.3) [14] | 14 (8.2) [14] | 45 (10.3) [45] |
| Injection site pain | 17 (10.0) [17] | 14 (14.3) [14] | 14 (8.2) [14] | 45 (10.3) [45] | |
| Hepatobiliary disorders | … | 2 (1.2) [2] | 0 (0.0) [0] | 0 (0.0) [0] | 2 (0.5) [2] |
| Hepatitis | 1 (0.6) [1] | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Drug-induced liver injury | 1 (0.6) [1] | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Injury, poisoning, and procedural complications | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.6) [1] | 1 (0.2) [1] | |
| Cardiotoxicity | 0 (0.0) [0] | 0 (0.0) [0] | 1 (0.6) [1] | 1 (0.2) [1] | |
| Investigations | 11 (6.5) [12] | 6 (6.1) [7] | 16 (9.4) [20] | 33 (7.5) [39] | |
| Aspartate aminotransferase increased | 6 (3.5) [6] | 1 (1.0) [1] | 6 (3.5) [6] | 13 (3.0) [13] | |
| Blood creatinine increased | 4 (2.4) [4] | 3 (3.1) [3] | 3 (1.8) [3] | 10 (2.3) [10] | |
| Electrocardiogram QT prolonged | 0 (0.0) [0] | 0 (0.0) [0] | 6 (3.5) [7] | 6 (1.4) [7] | |
| Alanine aminotransferase increased | 0 (0.0) [0] | 2 (2.0) [2] | 2 (1.2) [2] | 4 (0.9) [4] | |
| Blood bilirubin increased | 1 (0.6) [1] | 1 (1.0) [1] | 1 (0.6) [1] | 3 (0.7) [3] | |
| Liver function test increased | 1 (0.6) [1] | 0 (0.0) [0] | 1 (0.6) [1] | 2 (0.5) [2] | |
| Musculoskeletal and connective tissue disorders | … | 0 (0.0) [0] | 1 (1.0) [1] | 0 (0.0) [0] | 1 (0.2) [1] |
| Myalgia | 0 (0.0) [0] | 1 (1.0) [1] | 0 (0.0) [0] | 1 (0.2) [1] | |
| Renal and urinary disorders | … | 3 (1.8) [3] | 1 (1.0) [1] | 1 (0.6) [1] | 5 (1.1) [5] |
| Acute kidney injury | 3 (1.8) [3] | 1 (1.0) [1] | 1 (0.6) [1] | 5 (1.1) [5] | |
Data are presented as n (%) of patients with at least 1 event and number [n] of events.
Abbreviations: MF, miltefosine; PM, paromomycin; SSG, sodium stibogluconate.
Recruitment into arm 2 was discontinued.