Daptomycin for AHO – Supplemental Digital Content
1 Supplemental Digital Content 7. Adverse event rates by age cohort (safety population)
1 year old
Daptomycin (N=4)
Comparator (N=2)
Patients with ≥1 adverse event, n (%) 2 (50.0%) 1 (50.0%)
Patients with ≥1 severe adverse event, n (%)
- -
Patients with ≥1 serious adverse event, n (%) - -
Patients with ≥1 adverse event leading to treatment discontinuation, n (%)
- -
Patients with ≥1 treatment-related adverse event, n (%)* 1 (25.0%) - Patients with ≥1 serious treatment-related adverse event, n (%) - - Patients with ≥1 treatment-related adverse event leading to treatment
discontinuation, n (%)
- -
2-6 years old
Daptomycin (N=20)
Comparator (N=23)
Patients with ≥1 adverse event, n (%) 10 (50.0%) 14 (60.9%)
Patients with ≥1 severe adverse event, n (%)
1 (5.0%) 1 (4.3%)
Patients with ≥1 serious adverse event, n (%) 2 (10.0%) 4 (17.4%)
Patients with ≥1 adverse event leading to treatment discontinuation, n (%)
1 (5.0%) 3 (13.0%) Patients with ≥1 treatment-related adverse event, n (%)* 3 (15.0%) 3 (13.0%) Patients with ≥1 serious treatment-related adverse event, n (%) - - Patients with ≥1 treatment-related adverse event leading to treatment
discontinuation, n (%)
- 3 (13%)
7-11 years old
Daptomycin (N=25)
Comparator (N=25)
Patients with ≥1 adverse event, n (%) 8 (32.0%) 17 (68.0%)
Patients with ≥1 severe adverse event, n (%)
- -
Patients with ≥1 serious adverse event, n (%) - -
Patients with ≥1 adverse event leading to treatment discontinuation, n (%)
-
2 (8.0%)
Patients with ≥1 treatment-related adverse event, n (%)* - 5 (20.0%)
Patients with ≥1 serious treatment-related adverse event, n (%) - - Patients with ≥1 treatment-related adverse event leading to treatment
discontinuation, n (%)
-
1 (4.0%) 12-17 years old
Daptomycin (N=25)
Comparator (N=22)
Patients with ≥1 adverse event, n (%) 14 (56.0%) 13 (59.1%)
Patients with ≥1 severe adverse event, n (%)
1 (4.0%) -
Patients with ≥1 serious adverse event, n (%) 3 (12.0%) -
Patients with ≥1 adverse event leading to treatment discontinuation, n (%)
- 2 (9.1%)
Daptomycin for AHO – Supplemental Digital Content
2 Patients with ≥1 treatment-related adverse event, n (%)* 1 (4.0%) 5 (22.7%) Patients with ≥1 serious treatment-related adverse event, n (%) - - Patients with ≥1 treatment-related adverse event leading to treatment
discontinuation, n (%)
- 2 (9.1%)
Note: All adverse events (AEs) in this trial are reported as occurring from 1st dose of study drug through TOC, except serious AEs, which were reported from 1st dose of study drug through LFU; the reported AEs, including treatment-related AEs (i.e., assessed as related to IV study drug by the investigator), are therefore not limited to the time that patients were receiving IV study drug.
*All treatment-related AEs were mild or moderate in intensity, none were severe.
