Table 3.
Serious adverse events
| Patient ID | Adverse event term | Outcome | Severity | Expectedness | Relationship to study drug | CTCAE grade | Action taken | Serious? |
|---|---|---|---|---|---|---|---|---|
| 101001 | Dehydrationa | Resolved | Severe | Unexpected | Not related | Grade 3 | None | Yes |
| 101001 | Pulmonary embolism | Resolved | Moderate | Unexpected | Not related | Grade 2 | Not applicable | Yes |
| 101001 | Osteomyelitis | Resolved | Severe | Unexpected | Not related | Grade 3 | Not applicable | Yes |
Prior to vector administration.