Table 3.
Overview of treatment-emergent adverse events (TEAEs; safety analysis set)
| Trimodulin (n = 81) | Placebo (n = 79) | p value* | |
|---|---|---|---|
| Overall incidence | 75 (92.6) | 75 (94.9) | 0.746 |
| TEAEs with onset during infusion and up to 24 h after infusion end | 67 (82.7) | 67 (84.8) | 0.831 |
| Serious TEAEs | 62 (76.5) | 62 (78.5) | 0.850 |
| TEAEs with fatal outcomea | 20 (24.7) | 23 (29.1) | 0.594 |
| Discontinuation due to TEAEs | 2 (2.5) | 1 (1.3) | 1.000 |
| TEAEs by System Organ Class (≥ 5% of patients) | |||
| Blood and lymphatic system disorders | 33 (40.7) | 34 (43.0) | 0.873 |
| Cardiac disorders | 31 (38.3) | 27 (34.2) | 0.624 |
| Vascular disorders | 30 (37.0) | 30 (38.0) | 1.000 |
| Metabolism and nutrition disorders | 29 (35.8) | 29 (36.7) | 1.000 |
| Respiratory, thoracic, and mediastinal disorders | 29 (35.8) | 40 (50.6) | 0.079 |
| Gastrointestinal disorders | 27 (33.3) | 36 (45.6) | 0.145 |
| Infections and infestations | 27 (33.3) | 45 (57.0) | 0.004 |
| General disorders and administration-site conditions | 22 (27.2) | 31 (39.2) | 0.131 |
| Renal and urinary disorders | 20 (24.7) | 12 (15.2) | 0.167 |
| Psychiatric disorders | 18 (22.2) | 23 (29.1) | 0.367 |
| Investigations | 15 (18.5) | 13 (16.5) | 0.836 |
| Skin and subcutaneous tissue disorders | 14 (17.3) | 14 (17.7) | 1.000 |
| Nervous system disordersb | 13 (16.0) | 8 (10.1) | 0.350 |
| Hepatobiliary disorders | 12 (14.8) | 4 (5.1) | 0.063 |
| Musculoskeletal and connective tissue disorders | 9 (11.1) | 11 (13.9) | 0.639 |
| Injury, poisoning, and connective tissue disorders | 8 (9.9) | 8 (10.1) | 1.000 |
Data are n (%)
There were no adverse drug reactions leading to death in either treatment group
aSafety set includes patients with TEAE onset before day 28, but who died due to TEAE after day 28
bAll events were reported for single patients only, except for critical illness polyneuropathy and vocal cord paralysis, each reported for 2 (2.5%) patients in the trimodulin group, and headache, which was reported for 3 (3.7%) patients in the trimodulin group
*p values were calculated post hoc by Fisher exact test