Table 1 Summary of TEAEs emerging during the OLE up to Week 128 (SAF-OLE population)
Event, n (%) | Patients who started rhPTX-2 (n = 37) | Patients who continued rhPTX-2 (n = 74) | Total (n = 111) |
|---|---|---|---|
Any TEAE | 36 (97.3) | 69 (93.2) | 105 (94.6) |
Any TEAE leading to permanent study drug discontinuation | 10 (27.0) | 18 (24.3) | 28 (25.2) |
Any TEAE leading to hospitalization | 13 (35.1) | 25 (33.8) | 38 (34.2) |
Any mild TEAE | 31 (83.8) | 65 (87.8) | 96 (86.5) |
Any moderate TEAE | 28 (75.7) | 53 (71.6) | 81 (73.0) |
Any severe TEAE | 8 (21.6) | 23 (31.1) | 31 (27.9) |
Any life-threatening TEAE | 2 (5.4) | 1 (1.4) | 3 (2.7) |
Any TEAE possibly or probably related to study drug | 14 (37.8) | 24 (32.4) | 38 (34.2) |
Any IRR TEAE | 3 (8.1) | 7 (9.5) | 10 (9.0) |
Any respiratory decline TEAE | 8 (21.6) | 31 (41.9) | 39 (35.1) |
Any IPF exacerbations reported as TEAEs | 1 (2.7) | 6 (8.1) | 7 (6.3) |
Any serious TEAE | 15 (40.5) | 32 (43.2) | 47 (42.3) |
Any life-threatening serious TEAE | 2 (5.4) | 1 (1.4) | 3 (2.7) |
Death | 4 (10.8) | 10 (13.5) | 14 (12.6) |
Any serious TEAE possibly or probably related to study drug | 1 (2.7) | 1 (1.4) | 2 (1.8) |
Any IRR serious TEAE | 0 | 1 (1.4) | 1 (0.9) |
Any respiratory decline serious TEAE | 6 (16.2) | 16 (21.6) | 22 (19.8) |