AEs based on system organ class in the per-protocol cohort (n = 23)
| . | AEs . | AEs (CTCAE grade ≥3) . |
|---|---|---|
| Total | 241/23 (100.0%) | 5/4 (17.4%) |
| Gastrointestinal disorders | 87/16 (69.6%) | 1/1 (4.3%) |
| Reduction in general state of health, fatigue | 19/11 (47.8%) | |
| Infections | 13/9 (39.1%) | 3/2 (8.7%) |
| Skin and subcutaneous tissue disorders | 27/10 (43.5%) | |
| Nervous system disorders | 11/6 (26.1%) | |
| Blood and lymphatic system disorders | 11/7 (30.4%) | |
| Musculoskeletal and connective tissue disorders | 12/6 (26.1%) | |
| Vascular disorders | 23/6 (26.1%) | 1/1 (4.3%) |
| Abnormalities of laboratory values of liver enzymes, CRP, or blood count | 7/5 (21.7%) | |
| Injury or orthostatic problems | 7/4 (17.4%) | |
| Psychiatric disorders | 4/4 (17.4%) | |
| Respiratory, thoracic, and mediastinal disorders | 4/4 (17.4%) | |
| Metabolism and nutrition disorders | 4/3 (13.0%) | |
| Cardiac disorders | 3/2 (8.7%) | |
| Ear and labyrinth disorders | 2/2 (8.7%) | |
| Eye disorders | 2/2 (8.7%) | |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 2/2 (8.7%) | |
| Renal and urinary disorders | 2/2 (8.7%) | |
| Reproductive system and breast disorders | 1/1 (4.3%) |
| . | AEs . | AEs (CTCAE grade ≥3) . |
|---|---|---|
| Total | 241/23 (100.0%) | 5/4 (17.4%) |
| Gastrointestinal disorders | 87/16 (69.6%) | 1/1 (4.3%) |
| Reduction in general state of health, fatigue | 19/11 (47.8%) | |
| Infections | 13/9 (39.1%) | 3/2 (8.7%) |
| Skin and subcutaneous tissue disorders | 27/10 (43.5%) | |
| Nervous system disorders | 11/6 (26.1%) | |
| Blood and lymphatic system disorders | 11/7 (30.4%) | |
| Musculoskeletal and connective tissue disorders | 12/6 (26.1%) | |
| Vascular disorders | 23/6 (26.1%) | 1/1 (4.3%) |
| Abnormalities of laboratory values of liver enzymes, CRP, or blood count | 7/5 (21.7%) | |
| Injury or orthostatic problems | 7/4 (17.4%) | |
| Psychiatric disorders | 4/4 (17.4%) | |
| Respiratory, thoracic, and mediastinal disorders | 4/4 (17.4%) | |
| Metabolism and nutrition disorders | 4/3 (13.0%) | |
| Cardiac disorders | 3/2 (8.7%) | |
| Ear and labyrinth disorders | 2/2 (8.7%) | |
| Eye disorders | 2/2 (8.7%) | |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 2/2 (8.7%) | |
| Renal and urinary disorders | 2/2 (8.7%) | |
| Reproductive system and breast disorders | 1/1 (4.3%) |
The values are given as x/y (z.z%): x, number of events; y, number of patients with events; and z.z, percentage of patients with events.
CRP, C-reactive protein.