Table 3.
Adverse events of special interest
| Acute GVHD | ||||||
|---|---|---|---|---|---|---|
| DL | Organ | Enrollees, n (%) | Onset in relation to infusion | Max overall grade | Systemic steroids | Outcome |
| DL2 and DL5 | Skin | 2 of 24 (8) | 7 d after infusion for both | 1 | No | Resolved in 1 wk for both |
| DL2 | Upper GI | 1 of 24 (4) | 14 d after infusion | 2 | Yes | Resolved in 2 wk, steroid treatment discontinued |
| Chronic GVHD | ||||||
|---|---|---|---|---|---|---|
| DL | Organ | Enrollees, n (%) | Onset in relation to infusion | Max overall severity | Systemic treatment | Outcome |
| DL1 | Vaginal | 1 of 24 (4) | 1 y after infusion | Mild | No | Ongoing |
| DL3 | Skin | 1 of 24 (4) | 9 mo after infusion | Mild | No | Ongoing |
| DL3 | Joint | 1 of 24 (4) | 9 mo after infusion | Mild | No | Ongoing |
| DL3 | Eyes | 1 of 24 (4) | 9 mo after infusion | Mild | No | Ongoing |
| CRS | None at any dose level | |||||
| Neurotoxicity | None at any dose level | |||||
| Myelotoxicity (cytopenias persisting >28 d) | None at any dose level | |||||
CRS, cytokine release syndrome; Max, maximum grade seen in any of the patients at the indicated dose level.