Table 4 Summary of adverse events.
CTCAE Grade | |||||
|---|---|---|---|---|---|
Adverse Event Category (N (%)) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Overall |
Group A | |||||
Blood and lymphatic system disorders | 0 (0.0) | 0 (0.0) | 3 (30.0) | 0 (0.0) | 3 (6.8) |
Cardiac disorders | 1 (7.1) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 2 (4.5) |
Gastrointestinal disorders | 6 (42.9) | 11 (55.0) | 1 (10.0) | 0 (0.0) | 18 (40.9) |
General disorders and administration site conditions | 1 (7.1) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 3 (6.8) |
Infections and infestations | 0 (0.0) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 2 (4.5) |
Injury, poisoning and procedural complications | 1 (7.1) | 2 (10.0) | 0 (0.0) | 0 (0.0) | 3 (6.8) |
Investigations | 1 (7.1) | 0 (0.0) | 2 (20.0) | 0 (0.0) | 3 (6.8) |
Metabolism and nutrition disorders | 2 (14.3) | 0 (0.0) | 4 (40.0) | 0 (0.0) | 6 (13.6) |
Nervous system disorders | 1 (7.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.3) |
Psychiatric disorders | 1 (7.1) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 2 (4.5) |
Respiratory, thoracic and mediastinal disorders | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0 (0.0) | 1 (2.3) |
Total | 14 | 20 | 10 | 0 | 44 |
Group B | |||||
Blood and lymphatic system disorders | 3 (4.8) | 5 (10.6) | 2 (9.5) | 1 (100.0) | 11 (8.3) |
Ear and labyrinth disorders | 1 (1.6) | 1 (2.1) | 0 (0.0) | 0 (0.0) | 2 (1.5) |
Gastrointestinal disorders | 27 (42.9) | 20 (42.6) | 5 (23.8) | 0 (0.0) | 52 (39.4) |
General disorders and administration site conditions | 6 (9.5) | 5 (10.6) | 1 (4.8) | 0 (0.0) | 12 (9.1) |
Infections and infestations | 0 (0.0) | 1 (2.1) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
Injury, poisoning and procedural complications | 3 (4.8) | 2 (4.3) | 1 (4.8) | 0 (0.0) | 6 (4.5) |
Investigations | 1 (1.6) | 2 (4.3) | 4 (19.0) | 0 (0.0) | 7 (5.3) |
Metabolism and nutrition disorders | 10 (15.9) | 4 (8.5) | 6 (28.6) | 0 (0.0) | 20 (15.2) |
Musculoskeletal and connective tissue disorders | 1 (1.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
Nervous system disorders | 4 (6.3) | 4 (8.5) | 0 (0.0) | 0 (0.0) | 8 (6.1) |
Psychiatric disorders | 0 (0.0) | 1 (2.1) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
Respiratory, thoracic and mediastinal disorders | 1 (1.6) | 1 (2.1) | 0 (0.0) | 0 (0.0) | 2 (1.5) |
Skin and subcutaneous tissue disorders | 5 (7.9) | 1 (2.1) | 2 (9.5) | 0 (0.0) | 8 (6.1) |
Surgical and medical procedures | 1 (1.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
Total | 63 | 47 | 21 | 1 | 132 |
