Table 2.
Safety summary and summary of FMGX-related AEs by SOC and PT (safety analysis set)
| Parameters | IV cohort (600 mg q24h) n = 10 | PO cohort (500 mg q24h) n = 11 | Total N = 21 |
|||
|---|---|---|---|---|---|---|
| Events | n (%) | Events | n (%) | Events | n (%) | |
| AEs | 227 | 10 (100) | 131 | 11 (100) | 358 | 21 (100) |
| SAEs (any grade) | 9 | 5 (50) | 7 | 6 (54.5) | 16 | 11 (52.4) |
| AEs leading to withdrawal/discontinuation | 2 | 2 (20) | 1 | 1 (9.1) | 3 | 3 (14.3) |
| AEs leading to deaths | ||||||
| Related to FMGX treatment | — | 0 | — | 0 | — | 0 |
| Unrelated to FMGX treatment | 3 | 3a (30) | — | 0 | — | 3 (14.3) |
| FMGX-related AEs | 14 | 5 (50.0) | 12 | 4 (36.4) | 26 | 9 (42.9) |
| FMGX-related AEs by SOC and PT | ||||||
| General disorders and administration site conditions | 5 | 2 (20.0) | — | 0 | 5 | 2 (9.5) |
| Fatigue | 1 | 1 (10.0) | — | 0 | 1 | 1 (4.8) |
| Chills | 4 | 1 (10.0) | — | 0 | 4 | 1 (4.8) |
| Gastrointestinal disorders | 4 | 3 (30.0) | 3 | 2 (18.2) | 7 | 5 (23.8) |
| Nausea | 1 | 1 (10.0) | 3 | 2 (18.2) | 4 | 3 (14.3) |
| Diarrhoea | 1 | 1 (10.0) | — | 0 | 1 | 1 (4.8) |
| Vomiting | 2 | 2 (20.0) | — | 0 | 2 | 2 (9.5) |
| Infections and infestations | — | 0 | 2 | 1 (9.1) | 2 | 1 (4.8) |
| Pustular rash | — | 0 | 2 | 1 (9.1) | 2 | 1 (4.8) |
| Skin and subcutaneous tissue disorders | — | 0 | 5 | 2 (18.2) | 5 | 2 (9.5) |
| Rash | — | 0 | 1 | 1 (9.1) | 1 | 1 (4.8) |
| Intertrigo | — | 0 | 4 | 1 (9.1) | 4 | 1 (4.8) |
| Vascular disorders | 2 | 1 (10.0) | 1 | 1 (9.1) | 3 | 2 (9.5) |
| Hypertension | 2 | 1 (10.0) | — | 0 | 2 | 1 (4.8) |
| Vasculitis | — | 0 | 1 | 1 (9.1) | 1 | 1 (4.8) |
| Investigations | 1 | 1 (10.0) | 1 | 1 (9.1) | 2 | 2 (9.5) |
| ALT increased | 1 | 1 (10.0) | 1 | 1 (9.1) | 2 | 2 (9.5) |
| Psychiatric disorders | 2 | 2 (20.0) | — | 0 | 2 | 2 (9.5) |
| Delirium | 2 | 2 (20.0) | — | 0 | 2 | 2 (9.5) |
AEs, adverse events; FMGX, fosmanogepix; IV, intravenous; PO, oral; PT, preferred term; q24h, once a day; SOC, system organ class; SAE, treatment-emergent serious AE.
Total of four patients died during the study; one patient died before receiving any study drug and was considered a screen failure.