Number of patients experiencing grade 3-4 nonhematologic AEs during induction and consolidation
| . | Induction . | Con 1* . | Con 2† . | P (Induction vs Con 1) . | P (Con 1 vs Con 2) . |
|---|---|---|---|---|---|
| No. of patients for whom AE data are available | 120 (97%) | 112 (100%) | 110 (98%) | ||
| Cardiac‡ | 1 (1%) | 1 (1%) | 0 (0%) | 1.0 | 1.0 |
| Prolonged Q-Tc interval | 17 (14%) | 10 (9%) | 4 (4%) | .17 | .11 |
| Hepatic§ | 53 (44%) | 13 (12%) | 2 (2%) | < .0001 | .01 |
| Gastrointestinal¶ | 33 (28%) | 3 (3%) | 1 (1%) | < .0001 | .62 |
| Infection# | 91 (76%) | 21 (19%) | 3 (3%) | < .0001 | .0005 |
| Differentiation syndrome | 17 (14%) | 0 (0%) | 0 (0%) | .0005 | |
| Neurological** | 7 (6%) | 2 (2%) | 0 (0%) | .29 | .48 |
| Headache | 4 (3%) | 2 (2%) | 0 (0%) | .68 | .48 |
| Dermatological | 5 (4%) | 1 (1%) | 0 (0%) | .48 | |
| Respiratory†† | 2 (2%) | 1 (1%) | 0 (0%) | 1.0 | 1.0 |
| Metabolic‡‡ | 19 (16%) | 4 (4%) | 4 (4%) | .002 | 1.0 |
| Second malignancy | 0 (0%) | 1 (1%)§§ | 0 (0%) | 1.0 | 1.0 |
| . | Induction . | Con 1* . | Con 2† . | P (Induction vs Con 1) . | P (Con 1 vs Con 2) . |
|---|---|---|---|---|---|
| No. of patients for whom AE data are available | 120 (97%) | 112 (100%) | 110 (98%) | ||
| Cardiac‡ | 1 (1%) | 1 (1%) | 0 (0%) | 1.0 | 1.0 |
| Prolonged Q-Tc interval | 17 (14%) | 10 (9%) | 4 (4%) | .17 | .11 |
| Hepatic§ | 53 (44%) | 13 (12%) | 2 (2%) | < .0001 | .01 |
| Gastrointestinal¶ | 33 (28%) | 3 (3%) | 1 (1%) | < .0001 | .62 |
| Infection# | 91 (76%) | 21 (19%) | 3 (3%) | < .0001 | .0005 |
| Differentiation syndrome | 17 (14%) | 0 (0%) | 0 (0%) | .0005 | |
| Neurological** | 7 (6%) | 2 (2%) | 0 (0%) | .29 | .48 |
| Headache | 4 (3%) | 2 (2%) | 0 (0%) | .68 | .48 |
| Dermatological | 5 (4%) | 1 (1%) | 0 (0%) | .48 | |
| Respiratory†† | 2 (2%) | 1 (1%) | 0 (0%) | 1.0 | 1.0 |
| Metabolic‡‡ | 19 (16%) | 4 (4%) | 4 (4%) | .002 | 1.0 |
| Second malignancy | 0 (0%) | 1 (1%)§§ | 0 (0%) | 1.0 | 1.0 |
Consolidation cycle 1.
Consolidation cycle 2.
Conduction abnormalities other than Q-Tc prolongation or left ventricular systolic dysfunction.
Clinical liver failure or elevation of bilirubin, ALT, AST, or GGT.
Nausea, vomiting, diarrhea, mucositis, or enterocolitis.
Documented infection or febrile neutropenia.
Dizziness, mood alteration, musculoskeletal pain, or seizure.
Dyspnea or hypoxia not attributed to differentiation syndrome.
Hyperglycemia, hypertriglyceridemia, hypoalbuminemia, hypokalemia, hypophosphatemia, or renal failure.
Squamous cell carcinoma (SCC) of skin. Because the latency of skin cancer related to arsenic exposure is usually measured in years or decades (Levine T, Marcus W, Chen C. US Environmental Protection Agency Risk Assessment Forum: Special Report on Ingested Inorganic Arsenic. Available from: http://www.epa.gov/raf/publications/pdfs/EPA_625_3-87_013.PDF. Accessed April 2, 2012), it is unlikely that this SCC was a consequence of the therapeutic ATO used in this protocol.