Table 5.
Nonhematologic adverse events grade ≥3 occurring by system organ class in >10% of patients in a treatment group, with preferred term displayed if reported in ≥2 patients in a treatment group
| System organ class Preferred term | LDAC, n (%) | LDAC + volasertib, n (%) | ||||||
|---|---|---|---|---|---|---|---|---|
| CTCAE grade 3 | CTCAE grade 4 | CTCAE grade 5 | CTCAE grade 3-5 | CTCAE grade 3 | CTCAE grade 4 | CTCAE grade 5 | CTCAE grade 3-5 | |
| Febrile neutropenia | 3 (6.7) | 4 (8.9) | 0 | 7 (15.6) | 16 (38.1) | 5 (11.9) | 2 (4.8) | 23 (54.8) |
| Gastrointestinal | 3 (6.7) | 0 | 0 | 3 (6.7) | 9 (21.4) | 1 (2.4) | 0 | 10 (23.8) |
| Diarrhea | 1 (2.2) | 0 | 0 | 1 (2.2) | 4 (9.5) | 0 | 0 | 4 (9.5) |
| General disorders, administration site conditions | 8 (17.8) | 1 (2.2) | 0 | 9 (20.0) | 5 (11.1) | 1 (2.4) | 0 | 6 (14.3) |
| General health deterioration | 3 (6.7) | 1 (2.2) | 0 | 4 (8.9) | 2 (4.8) | 1 (2.4) | 0 | 3 (7.1) |
| Mucosal inflammation | 2 (4.4) | 0 | 0 | 2 (4.4) | 1 (2.4) | 0 | 0 | 1 (2.4) |
| Pyrexia | 1 (2.2) | 0 | 0 | 1 (2.2) | 3 (7.1) | 0 | 0 | 3 (7.1) |
| Infections and infestations | 3 (6.7) | 3 (6.7) | 4 (8.9) | 10 (22.2) | 16 (38.1) | 2 (4.8) | 2 (4.8) | 20 (47.6) |
| Cellulitis | 1 (2.2) | 2 (4.4) | 0 | 3 (6.7) | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Clostridium difficile infection | 0 | 0 | 0 | 0 | 2 (4.8) | 1 (2.4) | 0 | 3 (7.1) |
| Escherichia sepsis | 0 | 0 | 0 | 0 | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Lung infection | 0 | 0 | 0 | 0 | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Pneumonia | 0 | 0 | 2 (4.4) | 2 (4.4) | 7 (16.7) | 0 | 2 (4.8) | 9 (21.4) |
| Sepsis | 0 | 0 | 1 (2.2) | 1 (2.2) | 3 (7.1) | 1 (2.4) | 0 | 4 (9.5) |
| Urinary tract infection | 1 (2.2) | 0 | 0 | 1 (2.2) | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Investigations | 3 (6.7) | 2 (4.4) | 0 | 5 (11.1) | 3 (7.1) | 1 (2.4) | 0 | 4 (9.5) |
| CRP increased | 2 (4.4) | 0 | 0 | 2 (4.4) | 1 (2.4) | 0 | 0 | 1 (2.4) |
| Metabolism, nutrition disorders | 3 (6.7) | 0 | 0 | 3 (6.7) | 4 (9.5) | 3 (7.1) | 0 | 7 (16.7) |
| Hypoglycemia | 0 | 0 | 0 | 0 | 1 (2.4) | 1 (2.4) | 0 | 2 (4.8) |
| Hypokalemia | 1 (2.2) | 0 | 0 | 1 (2.2) | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Respiratory, thoracic, mediastinal disorders | 5 (11.1) | 1 (2.2) | 0 | 6 (13.3) | 6 (14.3) | 1 (2.4) | 3 (7.1) | 10 (23.8) |
| Dyspnea | 4 (8.9) | 1 (2.2) | 0 | 5 (11.1) | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Epistaxis | 0 | 0 | 0 | 0 | 2 (4.8) | 0 | 0 | 2 (4.8) |
| Hypoxia | 0 | 0 | 0 | 0 | 1 (2.4) | 0 | 1 (2.4) | 2 (4.8) |
| Pulmonary edema | 1 (2.2) | 0 | 0 | 1 (2.2) | 1 (2.4) | 1 (2.4) | 0 | 2 (4.8) |
| Respiratory failure | 1 (2.2) | 0 | 0 | 1 (2.2) | 0 | 0 | 2 (4.8) | 2 (4.8) |
CRP, C-reactive protein; CTCAE, Common Terminology Criteria for Adverse Events.