Table 4.
Summary of adverse events in Cohort 2
| Placebo (N = 6)a | 20 μg/ml rhNGF tid (N = 6)a | 60 μg/ml rhNGF tid (N = 6) | 180 μg/ml rhNGF tid (N = 7)a | Overall (N = 25)a | |
|---|---|---|---|---|---|
| Subjects with AEs | 3 (50.0) | 1 (16.7) | – | 2 (28.6) | 6 (24.0) |
| Number of AEs | 6 | 5 | – | 3 | 14 |
| Subjects with serious AEs | – | – | – | – | – |
| Subjects discontinued due to AEs | – | – | – | – | – |
| Severity (all AEs) | |||||
| Mild | 3 (50.0) [3] | 1 (16.7) [2] | – | 2 (28.6) [2] | 6 (24.0) [7] |
| Moderate | 2 (33.3) [3] | 1 (16.7) [3] | – | – | 3 (12.0) [6] |
| Severe | – | – | – | 1 (14.3) [1] | 1 (4.0) [1] |
| Total | 3 (50.0) [6] | 1 (16.7) [5] | – | 2 (28.6) [3] | 6 (24.0) [14] |
| Severity (suspected relationship) | |||||
| Mild | – | 1 (16.7) [1] | – | 1 (14.3) [1] | 2 (8.0) [2] |
| Moderate | 1 (16.7) [1] | 1 (16.7) [1] | – | – | 2 (8.0) [2] |
| Severe | – | – | – | – | – |
| Total | 1 (16.7) [1] | 1 (16.7) [2] | – | 1 (14.3) [1] | 3 (12.0) [4] |
| Relationship to study drug | |||||
| None (intercurrent event) | 1 (16.7) [2] | – | – | 1 (14.3) [1] | 2 (8.0) [3] |
| Unlikely | 2 (33.3) [2] | – | – | – | 2 (8.0) [2] |
| Possible | 1 (16.7) [1] | 1 (16.7) [3] | – | 1 (14.3) [1] | 3 (12.0) [5] |
| Probable | 1 (16.7) [1] | 1 (16.7) [2] | – | 1 (14.3) [1] | 3 (12.0) [4] |
| Highly probable | – | – | – | – | – |
rhNGF human recombinant nerve growth factor, tid three times daily, N = number of subjects studied, AEs adverse events
aData in parentheses denote percentage of subjects with AEs; data in square brackets denote number of AEs