T cell–related toxicities (arm A vs arm B)
| . | Grade I, n . | Grade II, n . | Grade III, n . | Totals, n (%) . | P . | ||||
|---|---|---|---|---|---|---|---|---|---|
| A . | B . | A . | B . | A . | B . | A . | B . | ||
| Event (0-48 h) | |||||||||
| Rigors/chills | 7 | 6 | 11 | 7 | 0 | 0 | 18 (64) | 13 (50) | NS |
| Nausea/vomiting | 1 | 7 | 0 | 0 | 0 | 0 | 1 (4) | 7 (27) | .02* |
| Fever | 3 | 4 | 0 | 0 | 0 | 0 | 3 (11) | 4 (15) | NS |
| Headache/pain | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 (12) | NS |
| Event (onset > 48 h) | |||||||||
| Rash | 19 | 19 | 4 | 4 | 0 | 0 | 23 (82) | 23 (88) | NS |
| Fever | 6 | 4 | 1 | 0 | 1 | 0 | 8 (29) | 4 (15) | NS |
| Gut GVHD | 1 | 0 | 3 | 2 | 0 | 1 | 4 (14) | 3 (12) | NS |
| Arthralgias | 3 | 4 | 0 | 1 | 0 | 0 | 3 (11) | 5 (19) | NS |
| Myalgias | 5 | 0 | 0 | 0 | 0 | 0 | 5 (18) | 0 | .05 |
| Headache/pain | 4 | 1 | 3 | 0 | 0 | 0 | 7 (25) | 1 (4) | .05 |
| Anorexia/nausea | 6 | 2 | 2 | 0 | 1 | 0 | 9 (32) | 2 (8) | .04* |
| Conjunctivitis | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 3 (12) | NS |
| Fatigue | 6 | 0 | 1 | 1 | 0 | 0 | 7 (25) | 1 (4) | .05 |
| Diarrhea | 10 | 3 | 6 | 1 | 2 | 1 | 18 (64) | 5 (19) | .001* |
| . | Grade I, n . | Grade II, n . | Grade III, n . | Totals, n (%) . | P . | ||||
|---|---|---|---|---|---|---|---|---|---|
| A . | B . | A . | B . | A . | B . | A . | B . | ||
| Event (0-48 h) | |||||||||
| Rigors/chills | 7 | 6 | 11 | 7 | 0 | 0 | 18 (64) | 13 (50) | NS |
| Nausea/vomiting | 1 | 7 | 0 | 0 | 0 | 0 | 1 (4) | 7 (27) | .02* |
| Fever | 3 | 4 | 0 | 0 | 0 | 0 | 3 (11) | 4 (15) | NS |
| Headache/pain | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 3 (12) | NS |
| Event (onset > 48 h) | |||||||||
| Rash | 19 | 19 | 4 | 4 | 0 | 0 | 23 (82) | 23 (88) | NS |
| Fever | 6 | 4 | 1 | 0 | 1 | 0 | 8 (29) | 4 (15) | NS |
| Gut GVHD | 1 | 0 | 3 | 2 | 0 | 1 | 4 (14) | 3 (12) | NS |
| Arthralgias | 3 | 4 | 0 | 1 | 0 | 0 | 3 (11) | 5 (19) | NS |
| Myalgias | 5 | 0 | 0 | 0 | 0 | 0 | 5 (18) | 0 | .05 |
| Headache/pain | 4 | 1 | 3 | 0 | 0 | 0 | 7 (25) | 1 (4) | .05 |
| Anorexia/nausea | 6 | 2 | 2 | 0 | 1 | 0 | 9 (32) | 2 (8) | .04* |
| Conjunctivitis | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 3 (12) | NS |
| Fatigue | 6 | 0 | 1 | 1 | 0 | 0 | 7 (25) | 1 (4) | .05 |
| Diarrhea | 10 | 3 | 6 | 1 | 2 | 1 | 18 (64) | 5 (19) | .001* |
Shown are toxicities which were possibly, probably, or definitely related to adoptive T-cell transfers either early (0-48 hours) after transfer or late (> 48 hours) after transfer. Severity grades of I, II and III are shown; no grade IV or V toxicities were observed. Other toxicities (not listed), such as hypertension, hypoxia/pulmonary, rash, and diarrhea (0-48 hours); cytopenias, neuropathy, hepatic(elevated aspartate aminotransferase/alanine aminotransferase), eosinophilia, renal/edema, mucositis, and mental status changes (> 48 hours) occurred in individual patients in both groups with no significant differences between the 2 groups.
GVHD indicates graft-versus-host disease.
Significant differences between total number of events for arms A and B for each type of toxicity (NS indicates P > .05).