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 |