Rates of AEs of all grades (≥ 3% in either group) and all grade 3 and 4 AEs reported during consolidation therapy with VTD or TD
| AE, n (%) . | VTD (n = 160) . | TD (n = 161) . | P . |
|---|---|---|---|
| All-grade AEs | |||
| PN | 26 (16.2%) | 8 (4.9%) | .001 |
| Infections (excluding herpes zoster) | 24 (15.0%) | 25 (15.5%) | .895 |
| Herpes zoster | 5 (3.1%) | 6 (3.7%) | .767 |
| Gastrointestinal events (excluding constipation) | 20 (12.5%) | 11 (6.8%) | .086 |
| Fever | 15 (9.3%) | 9 (5.5%) | .197 |
| Constipation | 11 (6.8%) | 6 (3.7%) | .208 |
| Skin rash | 8 (5.0%) | 5 (3.1%) | .389 |
| Thrombocytopenia | 9 (5.5%) | 0 | .002 |
| Any grade 3 or 4 AE | 17 (10.6%) | 15 (9.3%) | .696 |
| Nonhematologic grade 3 or 4 AEs | 15 (9.3%) | 14 (8.6%) | .832 |
| Gastrointestinal events (excluding constipation) | 3 (1.8%) | 1 (0.6%) | .311 |
| Infections (excluding herpes zoster) | 2 (1.2%) | 5 (3.1%) | .255 |
| Fever | 1 (0.6%) | 2 (1.2%) | .566 |
| Herpes zoster | 1 (0.6%) | 1 (0.6%) | .996 |
| Constipation | 1 (0.6%) | 1 (0.6%) | .996 |
| Skin rash | 1 (0.6%) | 1 (0.6%) | .996 |
| PN | 1 (0.6%) | 0 | .315 |
| Deep vein thrombosis | 1 (0.6%) | 1 (0.6%) | .996 |
| Hepatic | 1 (0.6%) | 0 | .315 |
| Pancreatitis | 1 (0.6%) | 0 | .315 |
| Hyperglycemia | 0 | 2 (1.2%) | .157 |
| AE, n (%) . | VTD (n = 160) . | TD (n = 161) . | P . |
|---|---|---|---|
| All-grade AEs | |||
| PN | 26 (16.2%) | 8 (4.9%) | .001 |
| Infections (excluding herpes zoster) | 24 (15.0%) | 25 (15.5%) | .895 |
| Herpes zoster | 5 (3.1%) | 6 (3.7%) | .767 |
| Gastrointestinal events (excluding constipation) | 20 (12.5%) | 11 (6.8%) | .086 |
| Fever | 15 (9.3%) | 9 (5.5%) | .197 |
| Constipation | 11 (6.8%) | 6 (3.7%) | .208 |
| Skin rash | 8 (5.0%) | 5 (3.1%) | .389 |
| Thrombocytopenia | 9 (5.5%) | 0 | .002 |
| Any grade 3 or 4 AE | 17 (10.6%) | 15 (9.3%) | .696 |
| Nonhematologic grade 3 or 4 AEs | 15 (9.3%) | 14 (8.6%) | .832 |
| Gastrointestinal events (excluding constipation) | 3 (1.8%) | 1 (0.6%) | .311 |
| Infections (excluding herpes zoster) | 2 (1.2%) | 5 (3.1%) | .255 |
| Fever | 1 (0.6%) | 2 (1.2%) | .566 |
| Herpes zoster | 1 (0.6%) | 1 (0.6%) | .996 |
| Constipation | 1 (0.6%) | 1 (0.6%) | .996 |
| Skin rash | 1 (0.6%) | 1 (0.6%) | .996 |
| PN | 1 (0.6%) | 0 | .315 |
| Deep vein thrombosis | 1 (0.6%) | 1 (0.6%) | .996 |
| Hepatic | 1 (0.6%) | 0 | .315 |
| Pancreatitis | 1 (0.6%) | 0 | .315 |
| Hyperglycemia | 0 | 2 (1.2%) | .157 |
Data are number (%).
AE indicates adverse event; VTD, bortezomib with thalidomide plus dexamethasone; TD, thalidomide plus dexamethasone; and PN, peripheral neuropathy.