Table 6. Treatment-emergent adverse events experienced by ≥5% of patients in either treatment group (treatment period).
| Pafuramidine 100 mg BID | Pentamidine 4 mg/kg QD | |||
|---|---|---|---|---|
| SOC | (N = 136) | (N = 137) | ||
| HLGT | n (%) | n (%) | ||
| Preferred Term | All Adverse Events | Treatment-Related Adverse Eventsa | All Adverse Events | Treatment-Related Adverse Eventsa |
| Total patients with at least 1 adverse eventb | 111 (81.6) | 54 (39.7) | 135 (98.5) | 127 (92.7) |
| Gastrointestinal disorders | 21 (15.4) | 10 (7.3) | 23 (16.8) | 12 (8.8) |
| Gastrointestinal signs and symptoms | 18 (13.2) | 9 (6.6) | 19 (13.9) | 12 (8.8) |
| Abdominal pain | 7 (5.1) | 1 (0.7) | 4 (2.9) | 2 (1.5) |
| Nausea | 4 (2.9) | 2 (1.5) | 11 (8.0) | 9 (6.6) |
| General disorders and administration site conditions | 46 (33.8) | 10 (7.4) | 61 (44.5) | 41 (29.9) |
| Administration site reactions | 0 | 0 | 35 (25.5) | 35 (25.5) |
| Injection site pain | 0 | 0 | 33 (24.1) | 33 (24.1) |
| Body temperature conditions | 43 (31.6) | 8 (5.9) | 33 (24.1) | 10 (7.3) |
| Pyrexia | 42 (30.9) | 8 (5.9) | 31 (22.6) | 10 (7.3) |
| Investigations | 33 (24.3) | 10 (7.4) | 111 (81.0) | 108 (78.8) |
| Haematology investigations (incl blood groups) | 17 (12.5) | 5 (3.7) | 11 (8.0) | 6 (4.4) |
| Haemoglobin decreased | 7 (5.1) | 2 (1.5) | 6 (4.4) | 3 (2.2) |
| Haemoglobin increased | 10 (7.4) | 3 (2.2) | 5 (3.6) | 3 (2.2) |
| Hepatobiliary investigationsb | 10 (7.4) | 4 (2.9) | 106 (77.4) | 105 (76.6) |
| Alanine aminotransferase increased | 2 (1.5) | 2 (1.5) | 72 (52.6) | 71 (51.8) |
| Aspartate aminotransferase increased | 7 (5.1) | 4 (2.9) | 104 (75.9) | 103 (75.2) |
| Metabolic, nutritional and blood gas investigations | 9 (6.6) | 3 (2.2) | 13 (9.5) | 10 (7.3) |
| Blood glucose decreased | 5 (3.7) | 2 (1.5) | 12 (8.8) | 10 (7.3) |
| Renal and urinary tract investigations and urinalysesb | 3 (2.2) | 0 | 12 (8.8) | 6 (4.4) |
| Blood creatinine increased | 3 (2.2) | 0 | 11 (8.0) | 5 (3.6) |
| Metabolism and nutrition disorders | 11 (8.1) | 1 (0.7) | 30 (21.9) | 24 (17.5) |
| Glucose metabolism disorders (including diabetes mellitus)b | 8 (5.9) | 0 | 25 (18.2) | 21 (15.3) |
| Hypoglycaemia | 8 (5.9) | 0 | 25 (18.2) | 21 (15.3) |
| Nervous system disorders | 24 (17.6) | 8 (5.9) | 26 (19.0) | 19 (13.9) |
| Headaches | 19 (14.0) | 5 (3.7) | 13 (9.5) | 4 (2.9) |
| Headache | 19 (14.0) | 5 (3.7) | 13 (9.5) | 4 (2.9) |
| Neurological disorders NEC | 9 (6.6) | 4 (2.9) | 16 (11.7) | 15 (10.9) |
| Dizziness | 9 (6.6) | 4 (2.9) | 6 (4.4) | 5 (3.6) |
| Dysgeusia | 0 | 0 | 11 (8.0) | 11 (8.0) |
| Skin and subcutaneous tissue disorders | 7 (5.1) | 2 (1.5) | 1 (0.7) | 0 |
| Epidermal and dermal conditions2 | 7 (5.1) | 2 (1.5) | 1 (0.7) | 0 |
| Vascular disorders | 64 (47.1) | 29 (21.3) | 86 (62.8) | 79 (57.7) |
| Decreased and nonspecific blood pressure disorders and shock2 | 60 (44.1) | 28 (20.6) | 85 (62.0) | 78 (56.9) |
| Hypotension | 60 (44.1) | 28 (20.6) | 85 (62.0) | 78 (56.9) |
BID = twice a day, HLGT = high-level group terms, NEC = not elsewhere classified, QD = once a day, SOC = system organ class
a Considered at least possibly related to study drug by the Investigator.
b Statistically significant (p<0.05) difference between treatment groups for overall incidence based on Fisher’s exact test.