Table 5

Overview of TEAEs

Disease status:
CRP requirement (mg/dL):
n:
IdiopathicPPSTotal
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)00002 (8.0)
Patients with ≥1 treatment-related serious TEAE, n (%)1 (8.3)00001 (4.0)
Patients with ≥1 TEAE leading to discontinuation, n (%)1 (8.3)00001 (4.0)
Patients with ≥1 TEAE leading to death, n (%)000000
Patients with TEAEs by severity, n (%)
 Mild9 (75.0)3 (100.0)4 (66.7)1 (100.0)2 (66.7)19 (76.0)
 Moderate2 (16.7)02 (33.3)004 (16.0)
 Severe1 (8.3)0001 (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.