TABLE 2.
Adverse events
| Placebo (N = 46) | MLC901 (N = 57) | |
|---|---|---|
| Number of patients experiencing AEs (including SAEs), n (%) | 20 (43%) | 32 (56%) |
| Number of AEs (including SAEs) | 34 | 43 |
| Severity | 24 (70%) | 26 (61%) |
| Mild | 8 (24%) | 10 (23%) |
| Moderate | 2 (6%) | 7 (16%) |
| Severe | ||
| Treatment related | ||
| Not related | 31 (91%) | 36 (84%) |
| Possibly related | 2 (6%) | 6 (14%) |
| Definitely related | 1 (3%) | 0 |
| Unknown | 0 | 1 (2%) |
| Action taken to study treatment | ||
| None | 31 (91%) | 34 (79%) |
| Discontinued permanently | 1 (3%) | 3 (7%) |
| Discontinued temporarily | 2 (6%) | 6 (14%) |
| Treatment given | ||
| Yes | 20 (59%) | 30 (70%) |
| No | 13 (38%) | 12 (28%) |
| Unknown | 1 (3%) | 1 (2%) |
| Outcome | ||
| Resolved, no sequelae | 23 (68%) | 30 (70%) |
| AE still present, no treatment | 3 (9%) | 2 (5%) |
| AE still present, being treated | 3 (9%) | 2 (5%) |
| Residual effects present, treated | 2 (6%) | 6 (13%) |
| Death | 0 | 1 (2%) |
| Unknown | 3 (9%) | 2 (5%) |
| Possible alternative explanation | ||
| Study procedure | 2 (6%) | 1 (2%) |
| Disease state | 3 (9%) | 6 (14%) |
| Concomitant medications | 1 (3%) | 2 (5%) |
| Concurrent illness | 3 (9%) | 5 (12%) |
| Other causes | 24 (71%) | 27 (63%) |
| Not applicable | 1 (3%) | 2 (5%) |
| Number of patients experiencing SAEs subjects, n (%) | 6 (13%) | 13 (23%) |
| Number of SAEs | 7 | 14 |
| SAE Criteria a | ||
| Death | 0 | 1 (7%) |
| Life threatening | 0 | 0 |
| Inpatient/prolonged hospitalization | 5 (71%) | 13 (93%) |
| Persistent disability/incapacity | 1 (14%) | 0 |
| Important medical event | 1 (14%) | 1 (7%) |
| Treatment related | ||
| Not related | 6 (86%) | 12 (86%) |
| Unlikely related | 1 (14%) | 1 (7%) |
| Possibly related | 0 | 1 (7%) |
| Action taken to study treatment | ||
| None | 5 (72%) | 9 (65%) |
| Interrupted temporarily | 1 (14%) | 3 (21%) |
| Discontinued/terminated study | 1 (14%) | 2 (14%) |
| Outcome | ||
| Complete recovery | 5 (72%) | 6 (43%) |
| Recovery with sequelae | 1 (14%) | 7 (50%) |
| Death | 0 | 1 (7%) |
| Unknown | 1 (14%) | 0 |
| Causality of SAE | ||
| Disease under study | 0 | 1 (7%) |
| Other illness | 4 (57%) | 4 (29%) |
| Concurrent medication / treatment | 1 (14%) | 1 (7%) |
| Others | 2 (29%) | 8 (57%) |
Notes: Number of patients in the study arm was the denominator for calculating proportion of patients experiencing AEs (SAEs); for the remaining proportions, the number of AEs (SAEs) was the denominator. .
Abbreviations: AE, adverse events; SAE, serious adverse event.
a
One SAE in the MLC901 arm satisfied two SAE criteria: inpatient/prolonged hospitalization, and important medical event.