Table 4.
All other treatment-related adverse events
| Incident | Enrollees, n | Onset in relation to infusion | Max grade | Treatment, if any | Status |
|---|---|---|---|---|---|
| DL1 | |||||
| Hepatitis | 1 | 7 d | 3 | Prednisone 0.5 mg/kg | Resolved 54 d later |
| Nausea/vomiting | 3 | 5 d, 2 d, and 1 mo | 1 | None | Resolved in 7 d |
| Skin dryness | 1 | 7 d | 1 | None | Resolved in 7 d |
| Incident | Patients, n | Onset in relation to infusion | Max grade | Treatment, if any | Status |
|---|---|---|---|---|---|
| DL2 | |||||
| Dry eyes | 2 | 7 d and 9 d | 1 | Topical treatments | Stable, Schirmer test not done |
| Hepatitis | 1 | 26 d | 2 | Coincident with grade 2 aGVHD above prednisone 0.5 mg/kg | Resolved in 2 wk |
| Anemia | 1 | 32 d | 1 | Coincident with grade 2 aGVHD above prednisone 0.5 mg/kg | Resolved in 7 d |
| Fatigue | 1 | 27 d | 2 | Coincident with RSV infection | Resolved in 7 d |
| Anorexia | 1 | 27 d | 2 | Coincident with RSV infection | Resolved in 7 d |
| Dizziness | 1 | 9 d | 1 | None | Resolved in 7 d |
| DL3 | |||||
| Diarrhea | 1 | 3 d | 1 | None | Resolved in 1 d |
| Fatigue | 2 | 7 d and 14 d | 1 | None | Resolved by day 28 |
| Hepatitis | 4 | 7 d, 7 d, 5 d, and 26 d | 1 | None | Resolved by day 60 in all |
| DL4 | |||||
| Diarrhea | 1 | 14 d | 1 | None | Resolved in 7 d |
| Lymphocytosis | 1 | 28 d | 2 | None | Ongoing without symptoms |
| DL5 | None | ||||
Max, maximum grade seen in any of the patients at the indicated dose level; RSV, respiratory syncytial virus.