Table 3a.
Adverse events and reactions in the Phase-1/2 study.
| N1 (%) [95% CI] n | A (N=90) |
B (N=90) |
C (N=90) |
D (N=90) |
Overall (N= 360) |
|---|---|---|---|---|---|
| Overall Adverse Events | |||||
| Any AE | 11 (12·22%) [6·26, 20·82] 11 |
9 (10·00%) [4·68, 18·14] 9 |
8 (8·89%) [3·92, 16·77] 10 |
14 (15·56%) [8·77, 24·72] 16 |
42 (11·67%) [8·54, 15·44] 46 |
| Any Local AE | 7 (7·78%) [3·18, 15·37] 7 |
3 (3·33%) [0·69, 9·43] 3 |
3 (3·33%) [0·69, 9·43] 4 |
12 (13·33%) [7·08, 22·13] 12 |
25 (6·94%) [4·54, 10·08] 26 |
| Solicited Local Adverse Events | |||||
| Injection site erythema | 1 (1·11%) [0·03, 6·04] 1 |
0 (0·00%) [NE] 0 | 0 (0·00%) [NE] 0 | 0 (0·00%) [NE] 0 | 1 (0·28%) [0·01, 1·54] 1 |
| Injection site pain | 6 (6·67%) [2·49, 13·95] 6 |
3 (3·33%) [0·69, 9·43] 3 |
2 (2·22%) [0·27, 7·80] 3 |
10 (11·11%) [5·46, 19·49] 10 |
21 (5·83%) [3·65, 8·78] 22 |
| Injection site swelling | 0 (0.00%) [0.00, 4.02] 0 | 0 (0.00%) [0.00, 4.02] 0 | 1 (1·11%) [0·03, 6·04] 1 |
2 (2·22%) [0·27, 7·80] 2 |
3 (0·83%) [0·17, 2·42] 3 |
| Any Systemic AEs | 4 (4·44%) [1·22, 10·99] 4 |
5 (5·56%) [1·83, 12·49] 5 |
5 (5·56%) [1·83, 12·49] 6 |
4 (4·44%) [1·22, 10·99] 4 |
18 (5·00%) [2·99, 7·79] 19 |
| Solicited Systemic Adverse Events | |||||
| Chills | 0 (0.00%) [0.00, 4.02] 0 | 0 (0.00%) [0.00, 4.02] 0 | 1 (1·11%) [0·03, 6·04] 1 |
0 (0.00%) [0.00, 4.02] 0 | 1 (0·28%) [0·01, 1·54] 1 |
| Pyrexia | 3 (3·33%) [0·69, 9·43] 3 |
2 (2·22%) [0·27, 7·80] 2 |
2 (2·22%) [0·27, 7·80] 2 |
1 (1·11%) [0·03, 6·04] 1 |
8 (2·22%) [0·96, 4·33] 8 |
| Myalgia | 0 (0.00%) [0.00, 4.02] 0 | 1 (1·11%) [0·03, 6·04] 1 |
1 (1·11%) [0·03, 6·04] 1 |
0 (0.00%) [0.00, 4.02] 0 | 2 (0·56%) [0·07, 1·99] 2 |
| Headache | 1 (1·11%) [0·03, 6·04] 1 |
2 (2·22%) [0·27, 7·80] 2 |
0 (0.00%) [0.00, 4.02] 0 | 3 (3·33%) [0·69, 9·43] 3 |
6 (1·67%) [0·61, 3·59] 6 |
| Urticaria | 0 (0.00%) [0.00, 4.02] 0 | 0 (0.00%) [0.00, 4.02] 0 | 2 (2·22%) [0·27, 7·80] 2 |
0 (0.00%) [0.00, 4.02] 0 | 2 (0·56%) [0·07, 1·99] 2 |
| Any Unsolicited Systemic AE | |||||
| Dyspepsia | 0 (0.00%) [0.00, 4.02] 0 | 1 (1·11%) [0·03, 6·04] 1 |
0 (0.00%) [0.00, 4.02] 0 | 0 (0.00%) [0.00, 4.02] 0 | 1 (0·28%) [0·01, 1·54] 1 |
AE: adverse event; NE: non estimable; CI: confidence interval.