Adverse events recorded in the 2 groups
| Events . | ATRA + LD-RTX (n = 112) . | LD-RTX (n = 56) . |
|---|---|---|
| Death | 1 (0.9) | 0 (0.0) |
| Patients reporting AEs | ||
| Any AEs | 79 (70.5) | 30 (53.6) |
| Any grade 3 to 4 AEs* | 4 (3.6) | 1 (1.8) |
| AE leading to discontinuation of therapy | 1 (0.9)† | 1 (1.8)‡ |
| AEs occurring in ≥2% of participants overall | ||
| Dry skin | 45 (40.2) | 0 (0.0) |
| Headache or dizziness | 21 (18.8) | 6 (10.7) |
| Fever | 16 (14.3) | 12 (21.4) |
| Upper respiratory infection | 4 (3.6) | 8 (14.3) |
| Urinary tract infection | 5 (4.5) | 4 (7.1) |
| Gastrointestinal infections | 2 (1.8) | 2 (3.6) |
| Muscle/joint pain | 2 (1.8) | 4 (7.1) |
| Rash acneiform | 3 (2.7) | 3 (5.4) |
| Any grade 3-4 AEs | ||
| Dry skin | 2 (1.8) | 0 (0.0) |
| Insomnia | 2 (1.8) | 0 (0.0) |
| Mood disorder | 0 (0.0) | 1 (1.8) |
| Events . | ATRA + LD-RTX (n = 112) . | LD-RTX (n = 56) . |
|---|---|---|
| Death | 1 (0.9) | 0 (0.0) |
| Patients reporting AEs | ||
| Any AEs | 79 (70.5) | 30 (53.6) |
| Any grade 3 to 4 AEs* | 4 (3.6) | 1 (1.8) |
| AE leading to discontinuation of therapy | 1 (0.9)† | 1 (1.8)‡ |
| AEs occurring in ≥2% of participants overall | ||
| Dry skin | 45 (40.2) | 0 (0.0) |
| Headache or dizziness | 21 (18.8) | 6 (10.7) |
| Fever | 16 (14.3) | 12 (21.4) |
| Upper respiratory infection | 4 (3.6) | 8 (14.3) |
| Urinary tract infection | 5 (4.5) | 4 (7.1) |
| Gastrointestinal infections | 2 (1.8) | 2 (3.6) |
| Muscle/joint pain | 2 (1.8) | 4 (7.1) |
| Rash acneiform | 3 (2.7) | 3 (5.4) |
| Any grade 3-4 AEs | ||
| Dry skin | 2 (1.8) | 0 (0.0) |
| Insomnia | 2 (1.8) | 0 (0.0) |
| Mood disorder | 0 (0.0) | 1 (1.8) |
Values are presented as numbers (percentages) of participants experiencing the event at least once.
Defined as any AE with significant symptoms requiring hospitalization, invasive intervention, transfusion, elective interventional radiological procedure or therapeutic endoscopy or operation, or any life-threatening or disabling AEs which are complicated by acute, life-threatening metabolic or cardiovascular complications or have a need for intensive care, emergent invasive procedure, emergent interventional radiological procedure or therapeutic endoscopy or operation.
Insomnia.
Mood disorder.