TABLE 4.
| A. Study 1 (IV-infused/oral switch of FMGX) | ||||
|---|---|---|---|---|
| TEAEsa E/n (%) |
PBO | FMGX | ||
| IV infusion (N = 3) |
Oral tablets (N = 3) |
IV infusion 2 × 1,000 and 600 mg (N = 9) |
Oral tablets 800 mg (N = 9) |
|
| All TEAEs | 5/2 (67) | 4/1 (33) | 31/8 (89) | 25/7 (78) |
| FMGX-related TEAEs | 0/0 (0) | 0/0 (0) | 0/0 (0) | 1/1 (11) |
| Nervous system disorders (somnolence) | 0/0 (0) | 0/0 (0) | 0/0 (0) | 1/1 (11) |
| TEAEs by severity | ||||
| Mild | 5/2 (67) | 4/1 (33) | 30/8 (89) | 24/7 (78) |
| Moderate | 0/0 (0) | 0/0 (0) | 1/1 (11) | 1/1 (11) |
| Musculoskeletal and connective tissue disorders (backache) | 0/0 (0) | 0/0 (0) | 1/1 (11) | 0/0 (0) |
| Nervous system disorders (headache) | 0/0 (0) | 0/0 (0) | 0/0 (0) | 1/1 (11) |
| Deaths and other SAEs | 0/0 (0) | 0/0 (0) | 0/0 (0) | 0/0 (0) |
| Withdrawn due to TEAEs | 0/0 (0) | 0/0 (0) | 0/0 (0) | 0/0 (0) |
TEAEs were classified according to MedDRA Version 21.0. Participants were counted once for multiple occurrences of a specific MedDRA Preferred Term.
TEAEs by PT described in Table S2.
TEAEs by PT described in Table S3.
Note: Participants with multiple events were counted under the category of their highest severity (TEAEs by severity) or most FMGX-related event (TEAEs by relationship to FMGX).
Cohorts: PBO 1, PBO BID on day 1 and QD on days 2 to 7 IV infusion; PBO 2, PBO BID on days 1 and 2 and QD on days 3 to 7 IV infusion; PBO 3, PBO BID on day 1 and QD on days 2 to 7 IV infusion with ondansetron; A, 1,500 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion; B, 900 mg BID on days 1 and 2 and 900 mg QD on days 3 to 7 FMGX IV infusion; C, 1,000 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion with ondansetron; D, 1,000 mg BID on day 1 and 750 mg QD on days 2 to 7 FMGX IV infusion; E, 1,000 mg BID on day 1 and 850 mg QD on days 2 to 7 FMGX IV infusion; F, 1,000 mg BID on day 1 and 900 mg QD on days 2 to 7 FMGX IV infusion.
%, percentage of the total number of participants per treatment that experienced the AEs ([n/N]*100); BID, twice daily; E, number of times the AEs occurred; FMGX, fosmanogepix; IV, intravenous; N, number of participants exposed; n, number of participants that experienced TEAEs; PBO, placebo; PT, preferred term; QD, once daily; SAE, serious adverse events; TEAEs, treatment-emergent adverse events.