TEAEa summary following enadenotucirev infusion
| Category | Preferred term | Number (%) of patients reporting AEs | Number of TEAEs grade ≥ 3 (all dosing groups) | |||
|---|---|---|---|---|---|---|
| Dose assigned (vp) | ||||||
| < 1 × 1012 vp(n = 6) | 1–3 × 1012 vp(n = 26) | > 3 × 1012 vp(n = 29) | All dosing groups(N = 61) | |||
| Any TEAE | 6 (100)[4] | 26 (100)[25] | 29 (100)[29] | 61 (100)[58] | 161[90] | |
| Any SAE | 1 (16.7) | 7 (26.9)[4] | 12 (41.4)[6] | 20 (32.8)[10] | ||
| TEAEs of interestb | ||||||
| Influenza-like symptoms | Chills, n (%) | 0 | 18 (69.2)[18] | 23 (79.3)[23] | 41 (67.2)[41] | 0 |
| Influenza-like illness, n (%) | 0 | 7 (26.9)[7] | 6 (20.7)[6] | 13 (21.3)[13] | 0 | |
| Pyrexia, n (%) | 2 (33.3)[1] | 20 (76.9)[19] | 23 (79.3)[23] | 45 (73.8)[43] | 2[2] | |
| Acute respiratory symptoms | Acute lung injury, n (%) | 0 | 0 | 1 (3.4)[1] | 1 (1.6)[1] | 1[1] |
| Dyspnea, n (%) | 1 (16.7) | 6 (23.1)[2] | 7 (24.1)[3] | 14 (23.0)[5] | 3[2] | |
| Hypoxia, n (%) | 0 | 1 (3.8)[1] | 5 (17.2)[5] | 6 (9.8)[6] | 9[9] | |
| Interstitial lung disease, n (%) | 0 | 0 | 1 (3.4)[1] | 1 (1.6)[1] | 1[1] | |
| Renal events | Acute kidney injury, n (%) | 0 | 1 (3.8) | 3 (10.3)[2] | 4 (6.6)[2] | 1 |
| Blood creatinine increased, n (%) | 0 | 0 | 2 (6.9)[1] | 2 (3.3)[1] | 0 | |
| Glomerulonephritis membranoproliferative, n (%) | 0 | 0 | 1 (3.4)[1] | 1 (1.6)[1] | 0 | |
| Nephrotic syndrome, n (%) | 0 | 1 (3.8)[1] | 0 | 1 (1.6)[1] | 1[1] | |
| Proteinuria, n (%) | 0 | 5 (19.2)[4] | 5 (17.2)[5] | 10 (16.4)[9] | 1[1] | |
| Renal failure, n (%) | 0 | 0 | 1 (3.4)[1] | 1 (1.6)[1] | 0 | |
| Hepatic events | ALT increased, n (%) | 1 (16.7) | 1 (3.8)[1] | 12 (41.4)[11] | 14 (23.0)[12] | 4[4] |
| AST increased, n (%) | 2 (33.3) | 2 (7.7)[1] | 10 (34.5)[9] | 14 (23.0)[10] | 5[4] | |
| Transaminases increased, n (%) | 0 | 2 (7.7)[2] | 2 (6.9)[2] | 4 (6.6)[4] | 1[1] | |
| Coagulation disorders | aPTT, n (%) | 0 | 2 (7.7)[2] | 5 (17.2)[4] | 7 (11.5)[6] | 1[1] |
| Fibrin D-dimer increased, n (%) | 0 | 5 (19.2)[4] | 9 (31.0)[8] | 14 (23.0)[12] | 5[4] | |
| International normalized ratio increased, n (%) | 1 (16.7) | 1 (3.8)[1] | 3 (10.3)[2] | 5 (8.2)[3] | 0 | |
| Hematological events | Anemia, n (%) | 1 (16.7) | 6 (23.1)[2] | 9 (31.0)[2] | 16 (26.2)[4] | 5[1] |
| Leukopenia/WBC count decreased, n (%) | 0 | 3 (11.5)[3] | 0 | 3 (4.9)[3] | 0 | |
| Lymphopenia/lymphocyte count decreased, n (%) | 0 | 4 (15.4)[4] | 2 (6.9)[2] | 6 (9.8)[6] | 8[7] | |
| Neutropenia/neutrophil count decreased, n (%) | 0 | 2 (7.7)[2] | 5 (17.2)[5] | 7 (11.5)[7] | 7[7] | |
| Thrombocytopenia/ platelet count decreased, n (%) | 1 (16.7)[1] | 5 (19.2)[5] | 13 (44.8)[13] | 19 (31.1)[19] | 4[4] | |
| Any TEAE relating to WBC count, n (%) | 0 | 6 (23.1)[6] | 6 (20.7)[6] | 12 (19.7)[12] | 0 | |
ALT alanine aminotransferase; aPTT activated partial thromboplastin time; AST aspartate aminotransferase; N (n) number of patients, SAE serious adverse event, TEAE treatment-emergent adverse event; vp viral particle(s); WBC white blood cell
aTEAEs are defined as any adverse event that occurs after the first administration of study treatment and through the end of the reporting period, any event that is considered treatment-related regardless of the start date of the event, or any event that is present at baseline and continues after the first dose of study treatment but worsens in intensity
bSelected preferred terms categorized as acute respiratory, renal, related to laboratory tests of hepatic transaminases, coagulation and hematological parameters, which were commonly related to study treatment
Numbers in bold and square brackets [] are the number of patients or number of events that were possibly, probably, or definitely related to study treatment