Table 3.
Summary of Treatment-Emergent Adverse Events—Modified Intention-to-Treat Set
| Arm 1, PM/MF 14 Days |
Arm 2, PM/MF 28 Daysa |
Arm 3, SSG/PM |
Overall | |
|---|---|---|---|---|
| Description | (n = 170) | (n = 98) | (n = 170) | (n = 438) |
| Any treatment-emergent adverse event (TEAE) | 89 (52.4) | 63 (64.3) | 87 (51.2) | 239 (54.6) |
| ȃAny at least severe TEAEb | 26 (15.3) | 14 (14.3) | 18 (10.6) | 58 (13.2) |
| ȃAny treatment-emergent serious adverse event (TESAE) | 5 (2.9) | 3 (3.1) | 3 (1.8) | 11 (2.5) |
| ȃAny TEAE leading to death | 1 (0.6) | 0 (0.0) | 3 (1.8) | 4 (0.9) |
| ȃAny TEAE leading to treatment discontinuation | 4 (2.4) | 0 (0.0) | 2 (1.2) | 6 (1.4) |
| Any treatment-emergent ADR | 59 (34.7) | 44 (44.9) | 31 (18.2) | 134 (30.6) |
| ȃAny at least severe treatment-emergent ADRb | 12 (7.1) | 4 (4.1) | 12 (7.1) | 28 (6.4) |
| ȃAny treatment-emergent serious ADR | 1 (0.6) | 1 (1.0) | 1 (0.6) | 3 (0.7) |
| ȃAny treatment-emergent ADR leading to death | 0 (0.0) | 0 (0.0) | 1 (0.6) | 1 (0.2) |
| ȃAny treatment-emergent ADR leading to treatment discontinuation | 4 (2.4) | 0 (0.0) | 2 (1.2) | 6 (1.4) |
Data are presented as n (%) of patients with at least 1 event.
Abbreviations: ADR, adverse drug reaction; MF, miltefosine; PM, paromomycin; SSG, sodium stibogluconate; TEAE, treatment-emergent adverse events.
Recruitment into arm 2 was discontinued.
Events with a severity classification as severe (Common Terminology Criteria for Adverse Events [CTCAE] grade 3), life-threatening (CTCAE grade 4), or death (CTCAE grade 5).