Article Figures & Data
Figures
- FIG. 1.
Drug administration and safety analysis schedule for tafenoquine and mefloquine. metHb, methemoglobin.
- FIG. 2.
Flow diagram of subject accountability during the study.
Tables
- TABLE 1.
Baseline demographic characteristics and previous malarial histories of subjects on tafenoquine and mefloquine for malaria prophylaxis
Characteristic Value for subjects who received: Tafenoquine (n = 492) Mefloquine (n = 162) No. (%) of subjects Gender Male 478 (97.2) 154 (95.1) Female 14 (2.8) 8 (4.9) Age (yr) 18-25 286 (58.1) 97 (59.9) 26-35 178 (36.2) 48 (29.6) 36-45 27 (5.5) 16 (9.9) 46-55 1 (0.2) 1 (0.6) Race White 484 (98.4) 160 (98.8) Aboriginal/Torres Strait Islander 4 (0.8) 1 (0.6) Other 4 (0.8) 1 (0.6) Previous history of malaria 15 (3.0) 4 (2.5) Having malaria attacks in 6 mo prior to deployment 9 (1.8) 1 (0.6) Age Mean (SD) 25.4 (5.3) 26.0 (6.5) Range 18-47 18-51 Weight (kg) Mean (SD) 80.9 (11.9) 81.3 (12.2) Range 50-135 53-135 Height (cm) Mean (SD) 177.8 (7.0) 177.1 (6.7) Range 155-198 157-192 - TABLE 2.
Ophthalmic assessments of a subgroup of subjects on tafenoquine or mefloquine
Activity Screening Posttreatment assessment Visual field tests Amsler grid Amsler grid Humphrey perimetry Visual acuity Snellen chart Snellen chart Color vision Ishihara test Ishihara test Standard pseudoisochromatic plates part 2 Farnsworth-Munsell 100 hue test Physical examination Fundoscopy Fundoscopy Corneal examination Corneal examination Digital retinal photography Digital corneal photography Fundus fluorescein angiograma ↵a Small number of subjects with possible retinal findings only.
- TABLE 3.
Adverse events occurring in >5% of subjects on tafenoquine or mefloquine (prophylactic phase)a
Adverse event No. (%) of subjects by AE severity and treatment group Mild Moderate Severe Total Tafenoquine Mefloquine Tafenoquine Mefloquine Tafenoquine Mefloquine Tafenoquine Mefloquine At least one AE 431 (88) 140 (86) 194 (39) 46 (28) 18 (4) 3 (2) 454 (92) 143 (88) Gastrointestinal Gastroenteritis 109 (22) 36 (22) 80 (16) 17 (11) 6 (1) 0 182 (37) 51 (32) Diarrhea 77 (16) 28 (17) 0 2 (1) 1 (<1) 0 77 (16) 30 (19) Nausea 27 (6) 13 (8) 1 (<1) 0 0 0 28 (6) 13 (8) Abdominal pain 19 (4) 11 (7) 5 (1) 3 (2) 1 (<1) 0 24 (5) 13 (8) Vomiting 19 (4) 8 (5) 2 (<1) 1 (<1) 0 0 21 (4) 8 (5) Musculoskeletal Injury 149 (30) 46 (28) 45 (9) 4 (3) 3 (<1) 2 (1) 178 (36) 49 (30) Back pain 65 (13) 24 (15) 12 (2) 2 (1) 0 0 74 (15) 26 (16) Arthralgia 52 (11) 17 (11) 9 (2) 1 (<1) 0 0 55 (11) 18 (11) Respiratory URTI 97 (20) 30 (19) 6 (1) 2 (1) 0 0 101 (21) 32 (20) Pharyngitis 24 (5) 2 (1) 2 (<1) 1 (<1) 0 0 25 (5) 3 (2) Dermatological Rash 70 (14) 20 (12) 1 (<1) 1 (<1) 0 0 70 (14) 21 (13) Fungal dermatitis 43 (9) 8 (5) 1 (<1) 0 0 0 44 (9) 8 (5) Headache (constitutional AE) 59 (12) 18 (11) 2 (<1) 2 (1) 0 0 61 (12) 20 (12) Viral infection 23 (5) 7 (4) 16 (3) 6 (4) 1 (<1) 0 39 (8) 13 (8) ↵a In total, there were 492 tafenoquine subjects and 162 mefloquine subjects. AE, adverse event; URTI, upper respiratory tract infection.
- TABLE 4.
Neuropsychiatric events in subjects on tafeoquine or mefloquine (prophylactic phase)a
Adverse event No. (%) of subjects by AE severity and treatment group Mild Moderate Total Tafenoquine Mefloquine Tafenoquine Mefloquine Tafenoquine Mefloquine Vertigo 22 (5) 7 (4) 0 1 (<1) 22 (5) 8 (5) Somnolence 12 (2) 6 (4) 0 0 12 (2) 6 (4) Abnormal dreams 7 (1) 2 (1) 0 0 7 (1) 2 (1) Dizziness 5 (1) 2 (1) 0 0 5 (1) 2 (1) Insomnia 4 (<1) 3 (2) 1 (<1) 0 5 (1) 3 (2) Abnormal coordination 2 (<1) 1 (<1) 0 0 2 (<1) 1 (<1) Anxiety 2 (<1) 0 0 0 2 (<1) 0 Agitation 2 (<1) 0 0 0 2 (<1) 0 Euphoria 2 (<1) 0 0 0 2 (<1) 0 Tremor 2 (<1) 0 0 0 2 (<1) 0 Depression 0 0 1 (<1) 1 (<1) 1 (<1) 1 (<1) Paroniria 1 (<1) 0 0 0 1 (<1) 0 Amnesia 1 (<1) 0 0 0 1 (<1) 0 ↵a In total, there were 492 tafenoquine subjects and 162 mefloquine subjects. There were no severe adverse events (AEs) of this type.
- TABLE 5.
Table of adverse events attributed as related to study drug during prophylactic phase in the safety populationa
Adverse event No. (%) of patients in treatment group Tafenoquine (n = 492) Mefloquine (n = 162) At least one AE 66 (13.4) 19 (11.7) Nausea 14 (2.8) 4 (2.5) Vertigo 10 (2.0) 2 (1.2) Diarrhea 9 (1.8) 3 (1.9) Abdominal pain 7 (1.4) 2 (1.2) Abnormal dreaming 6 (1.2) 1 (0.6) Somnolence 6 (1.2) 1 (0.6) Headache 3 (0.6) 2 (1.2) Insomnia 3 (0.6) 2 (1.2) ↵a Events occurring in >1% of subjects are shown. AE, adverse event.
