Disease status: CRP requirement (mg/dL): n: | Idiopathic | PPS | Total | |||
Active*
>1 12 | Active† ≤1 3 | CS-dep‡ N/A 6 | Active§ >1 1 | CS-dep¶ N/A 3 | All*†‡§¶ N/A 25 | |
Patients with ≥1 TEAE, n (%) | 12 (100.0) | 3 (100.0) | 6 (100.0) | 1 (100.0) | 3 (100.0) | 25 (100.0) |
Patients with ≥1 treatment-related TEAE, n (%) | 9 (75.0) | 2 (66.7) | 3 (50.0) | 1 (100.0) | 2 (66.7) | 17 (68.0) |
Patients with ≥1 serious TEAE, n (%) | 2 (16.7) | 0 | 0 | 0 | 0 | 2 (8.0) |
Patients with ≥1 treatment-related serious TEAE, n (%) | 1 (8.3) | 0 | 0 | 0 | 0 | 1 (4.0) |
Patients with ≥1 TEAE leading to discontinuation, n (%) | 1 (8.3) | 0 | 0 | 0 | 0 | 1 (4.0) |
Patients with ≥1 TEAE leading to death, n (%) | 0 | 0 | 0 | 0 | 0 | 0 |
Patients with TEAEs by severity, n (%) | ||||||
Mild | 9 (75.0) | 3 (100.0) | 4 (66.7) | 1 (100.0) | 2 (66.7) | 19 (76.0) |
Moderate | 2 (16.7) | 0 | 2 (33.3) | 0 | 0 | 4 (16.0) |
Severe | 1 (8.3) | 0 | 0 | 0 | 1 (33.3) | 2 (8.0) |
*Part 1.
†Part 2.
‡Part 3.
§Part 4.
¶Part 5.
CRP, C reactive protein; CS-dep, corticosteroid dependent; PPS, postpericardiotomy syndrome; TEAEs, treatment-emergent adverse events.