Table 3.
Numbers (%) of participants experiencing serious adverse events during first half of part 3 (approximately months 22–39 after the first dose/months 19–36 after the second dose; safety set data)
| Placebo (n = 6687) | TAK-003 (n = 13380) | |
|---|---|---|
| Any | 234 (3.5%) | 386 (2.9%) |
| Mild | 21 (0.3%) | 48 (0.4%) |
| Moderate | 182 (2.7%) | 291 (2.2%) |
| Severe | 31 (0.5%) | 47 (0.4%) |
| Related to investigational producta | 0 (0) | 0 (0) |
| Related to study procedures | 0 (0) | 0 (0) |
| Leading to withdrawal of investigational product or study discontinuation | 2 (<0.1%) | 5 (<0.1%) |
| Deaths | 2 (<0.1%) | 5 (<0.1%) |
| Related to investigational productb | 0 (0.0%) | 0 (0.0%) |
As assessed by the sponsor or by the investigator (blinded).
Causes of death were adenocarcinoma of colon, road traffic accident, wound by sharp element, traumatic lung injury secondary to drowning, completed suicide, multiple organ dysfunction secondary to suicide attempt, and traumatic brain injury.