TABLE 4.
SOLICITED AND UNSOLICITED EVENTS
| Placebo (n = 11) n (%) | Group 1 (n = 7) n (%) | Group 2 (n = 7) n (%) | Group 3 (n = 9) n (%) | Group 4 (n = 6) n (%) | Total (n = 40) n (%) | |
|---|---|---|---|---|---|---|
| Subjects with at least one adverse event | 9 (81.8) | 7 (100%) | 6 (85.7%) | 8 (88.9%) | 5 (83.3%) | 35 (100%) |
| Solicited events | ||||||
| Arthralgia | — | 2 (28.6) | — | 1 (11.1) | — | 3 (8.6) 33 |
| Conjunctivitis | — | — | — | 1 (11.1) | — | 1 (2.9) 3 |
| Diarrhea | — | 3 (42.9) | — | — | — | 3 (8.6) |
| Dysuria | 1 (9.1) | — | — | 2 (22.2) | — | 3 (8.6) |
| Injection site erythema | — | — | 1 (14.3) | 1 (11.1) | — | 2 (5.7) |
| Injection site pain | 2 (18.2) | 1 (14.3) | 1 (14.3) | 5 (55.5) | 4 (66.7) | 13 (37.1) |
| Injection site swelling | — | — | 2 (28.6) | — | — | 2 (5.7) |
| Malaise | 3 (27.3) | 2 (28.6) | 2 (28.6) | 4 (44.4) | 1 (16.7) | 12 (34.3) |
| Myalgia | 1 (9.1) | 2 (28.6) | 1 (14.3) | 3 (33.3) | 2 (33.4) | 9 (25.7) |
| Fever | — | — | 1 (14.3) | 1 (11.1) | — | 2 (5.7) |
| Rash | 1 (9.1) | — | — | — | — | 1 (2.9) |
| Sore throat | 1 (9.1) | 2 (28.6) | 2 (28.6) | — | 3 (50) | 8 (22.9) |
| Upper respiratory tract infection | 2 (18.2) | 3 (42.9) | 1 (14.3) | 1 (11.1) | 1 (16.7) | 8 (22.9) |
| Unsolicited events | ||||||
| Abdominal pain | — | — | 1 (14.3) | — | — | 1 (2.9) |
| Activated partial thromboplastin time prolonged | — | — | 1 (14.3) | — | 1 (16.7) | 2 (5.7) |
| Acute HIV infection | — | — | 1 (14.3) | — | — | 1 (2.9) |
| Alanine aminotransferase increased | — | 1 (14.3) | — | — | — | 1 (2.9) |
| Aspartate aminotransferase increased | — | 1 (14.3) | — | — | — | 1 (2.9) |
| Blood creatine phosphokinase increased | 4 (36.4) | 2 (28.6) | 3 (42.9) | 2 (22.2) | 2 (33.4) | 13 (37.1) |
| Blood pressure systolic increased | 1 (9.1) | — | — | 1 (11.1) | 1 (16.7) | 3 (8.6) |
| Bradycardia | — | 1 (14.3) | 1 (14.3) | — | — | 2 (5.7) |
| Cystitis | 1 (9.1) | — | — | — | — | 1 (2.9) |
| Dysmenorrhea | 1 (9.1) | 1 (14.3) | — | — | — | 2 (5.7) |
| Dyspepsia | — | — | — | 1 (11.1) | — | 1 (2.9) |
| Escherichia urinary tract infection | — | — | — | 1 (11.1) | 1 (16.7) | 2 (5.7) |
| γ-Glutamyltransferase increased | 1 (9.1) | — | — | — | 1 (16.7) | 2 (5.7) |
| Hematuria | — | — | — | 2 (22.2) | 2 (33.4) | 4 (11.4) |
| Hemoglobin decreased | 3 (27.3) | 4 (57.1) | 2 (28.6) | 3 (33.3) | 4 (66.7) | 16 (45.7) |
| Headache | 2 (18.2) | 4 (57.1) | 1 (14.3) | 2 (22.2) | 1 (16.7) | 10 (28.6) |
| Hypertension | 1 (9.1) | — | — | — | — | 1 (2.9) |
| Lymphocyte count decreased | 1 (9.1) | 1 (14.3) | — | — | — | 2 (5.7) |
| Nausea | 1 (9.1) | — | 2 (28.6) | — | — | 3 (8.6) |
| Neutrophil count decreased | — | — | — | 2 (22.2) | — | 2 (5.7) |
| Ocular hyperemia | — | 1 (14.3) | — | — | — | 1 (2.9) |
| Pain in extremity | 1 (9.1) | 1 (14.3) | — | — | — | 2 (5.7) |
| Proteinuria | — | — | 1 (14.3) | 3 (33.3) | 1 (16.7) | 5 (14.3) |
| Prothrombin time prolonged | — | 1 (14.3) | 1 (14.3) | — | — | 2 (5.7) |
| Schistosomiasis | — | — | — | 1 (11.1) | — | 1 (2.9) |
| Sinusitis | — | 1 (14.3) | — | — | — | 1 (2.9) |
| Suicide attempt | — | — | 1 (14.3) | — | — | 1 (2.9) |
| Tachycardia | — | — | 2 (28.6) | — | — | 2 (5.7) |
| Tonsillitis | — | — | — | 1 (11.1) | — | 1 (2.9) |
| Toothache | — | 1 (14.3) | — | — | — | 1 (2.9) |
| Vaginal infection | 1 (9.1) | — | — | — | — | 1 (2.9) |
| White blood cell count increased | — | 1 (14.3) | 1 (14.3) | — | 1 (16.7) | 3 (8.6) |