TEAEs according to the severity-safety population (experienced by more than 1 patient)
| AE . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total . |
|---|---|---|---|---|---|---|
| Blood and lymphatic system disorders | 3 (5.8%) | 9 (17.3%) | 19 (36.5%) | 6 (11.5%) | 0 | 37 (71.2%) |
| Anemia | 2 (3.8%) | 9 (17.3%) | 11 (21.2%) | 0 | 0 | 22 (42.3%) |
| Febrile Neutropenia | 0 | 1 (1.9%) | 6 (11.5%) | 0 | 0 | 7 (13.5%) |
| Leukopenia | 1 (1.9%) | 0 | 0 | 1 (1.9%) | 0 | 2 (3.8%) |
| Lymphopenia | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Neutropenia | 1 (1.9%) | 2 (3.8%) | 5 (9.6%) | 5 (9.6%) | 0 | 13 (25.0%) |
| Thrombocytopenia | 0 | 2 (3.8%) | 0 | 1 (1.9%) | 0 | 3 (5.8%) |
| Cardiac disorders, tachycardia | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 0 | 3 (5.8%) |
| Ear and labyrinth disorders, ear pain | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Eye disorders | 11 (21.2%) | 2 (3.8%) | 0 | 0 | 0 | 13 (25.0%) |
| Dry eye | 6 (11.5%) | 0 | 0 | 0 | 0 | 6 (11.5%) |
| Lacrimation increased | 5 (9.6%) | 1 (1.9%) | 0 | 0 | 0 | 6 (11.5%) |
| Vision blurred | 8 (15.4%) | 1 (1.9%) | 0 | 0 | 0 | 9 (17.3%) |
| Gastrointestinal disorders | 20 (38.5%) | 18 (34.6%) | 8 (15.4%) | 0 | 0 | 46 (88.5%) |
| Abdominal pain | 2 (3.8%) | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 5 (9.6%) |
| Constipation | 18 (34.6%) | 10 (19.2%) | 2 (3.8%) | 0 | 0 | 30 (57.7%) |
| Diarrhea | 9 (17.3%) | 5 (9.6%) | 0 | 0 | 0 | 14 (26.9%) |
| Dyspepsia | 2 (3.8%) | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Gastritis | 0 | 2 (3.8%) | 0 | 0 | 0 | 2 (3.8%) |
| Gastroesophageal reflux disease | 4 (7.7%) | 4 (7.7%) | 1 (1.9%) | 0 | 0 | 9 (17.3%) |
| Nausea | 12 (23.1%) | 10 (19.2%) | 4 (7.7%) | 0 | 0 | 26 (50.0%) |
| Oral pain | 5 (9.6%) | 6 (11.5%) | 1 (1.9%) | 0 | 0 | 12 (23.1%) |
| Stomatitis | 5 (9.6%) | 4 (7.7%) | 2 (3.8%) | 0 | 0 | 11 (21.2%) |
| Vomiting | 6 (11.5%) | 5 (9.6%) | 4 (7.7%) | 0 | 0 | 15 (28.8%) |
| General disorders and administration site conditions | 16 (30.8%) | 23 (44.2%) | 8 (15.4%) | 1 (1.9%) | 0 | 48 (92.3%) |
| Chest pain | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Fatigue | 16 (30.8%) | 19 (36.5%) | 3 (5.8%) | 1 (1.9%) | 0 | 39 (75.0%) |
| Local swelling | 2 (3.8%) | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Mucosal inflammation | 15 (28.8%) | 8 (15.4%) | 4 (7.7%) | 0 | 0 | 27 (51.9%) |
| Edema peripheral | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 0 | 3 (5.8%) |
| Pyrexia | 5 (9.6%) | 4 (7.7%) | 0 | 0 | 0 | 9 (17.3%) |
| Infections and infestations | 7 (13.5%) | 9 (17.3%) | 4 (7.7%) | 1 (1.9%) | 1 (1.9%) | 22 (42.3%) |
| Candida infection | 0 | 3 (5.8%) | 0 | 0 | 0 | 3 (5.8%) |
| Nasopharyngitis | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Pneumonia | 0 | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 2 (3.8%) |
| Upper respiratory tract infection | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Investigations | 9 (17.3%) | 5 (9.6%) | 7 (13.5%) | 5 (9.6%) | 0 | 26 (50.0%) |
| Alanine aminotransferase level increased | 6 (11.5%) | 0 | 2 (3.8%) | 0 | 0 | 8 (15.4%) |
| Aspartate aminotransferase level increased | 5 (9.6%) | 1 (1.9%) | 1 (1.9%) | 1 (1.9%) | 0 | 8 (15.4%) |
| Blood creatinine level increased | 2 (3.8%) | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Hematocrit level decreased | 0 | 2 (3.8%) | 0 | 0 | 0 | 2 (3.8%) |
| Lymphocyte count decreased | 1 (1.9%) | 1 (1.9%) | 2 (3.8%) | 1 (1.9%) | 0 | 5 (9.6%) |
| Neutrophil count decreased | 0 | 0 | 2 (3.8%) | 3 (5.8%) | 0 | 5 (9.6%) |
| Platelet count decreased | 3 (5.8%) | 3 (5.8%) | 0 | 1 (1.9%) | 0 | 7 (13.5%) |
| Weight decreased | 5 (9.6%) | 0 | 0 | 0 | 0 | 5 (9.6%) |
| White blood cell count decreased | 0 | 3 (5.8%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Metabolism and nutrition disorders | 15 (28.8%) | 5 (9.6%) | 3 (5.8%) | 0 | 0 | 23 (44.2%) |
| Decreased appetite | 10 (19.2%) | 2 (3.8%) | 0 | 0 | 0 | 12 (23.1%) |
| Dehydration | 1 (1.9%) | 3 (5.8%) | 1 (1.9%) | 0 | 0 | 5 (9.6%) |
| Hyperglycemia | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Hyperuricemia | 4 (7.7%) | 0 | 0 | 0 | 0 | 4 (7.7%) |
| Hypokalemia | 5 (9.6%) | 1 (1.9%) | 0 | 0 | 0 | 6 (11.5%) |
| Hypomagnesemia | 4 (7.7%) | 0 | 0 | 0 | 0 | 4 (7.7%) |
| Musculoskeletal and connective tissue disorders | 10 (19.2%) | 8 (15.4%) | 1 (1.9%) | 1 (1.9%) | 0 | 20 (38.5%) |
| Arthralgia | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Back pain | 1 (1.9%) | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Bone pain | 2 (3.8%) | 3 (5.8%) | 0 | 0 | 0 | 5 (9.6%) |
| Muscle spasms | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Myalgia | 5 (9.6%) | 3 (5.8%) | 0 | 0 | 0 | 8 (15.4%) |
| Nervous system disorders | 22 (42.3%) | 6 (11.5%) | 1 (1.9%) | 0 | 0 | 29 (55.8%) |
| Dizziness | 10 (19.2%) | 3 (5.8%) | 0 | 0 | 0 | 13 (25.0%) |
| Headache | 5 (9.6%) | 0 | 1 (1.9%) | 0 | 0 | 6 (11.5%) |
| Hypoesthesia | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Memory impairment | 5 (9.6%) | 2 (3.8%) | 0 | 0 | 0 | 7 (13.5%) |
| Neuropathy peripheral | 9 (17.3%) | 2 (3.8%) | 0 | 0 | 0 | 11 (21.2%) |
| Peripheral sensory neuropathy | 6 (11.5%) | 1 (1.9%) | 0 | 0 | 0 | 7 (13.5%) |
| Psychiatric disorders | 11 (21.2%) | 4 (7.7%) | 0 | 0 | 0 | 15 (28.8%) |
| Anxiety | 1 (1.9%) | 2 (3.8%) | 0 | 0 | 0 | 3 (5.8%) |
| Depression | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Insomnia | 8 (15.4%) | 2 (3.8%) | 0 | 0 | 0 | 10 (19.2%) |
| Renal and urinary disorders | 7 (13.5%) | 1 (1.9%) | 0 | 0 | 0 | 8 (15.4%) |
| Dysuria | 4 (7.7%) | 0 | 0 | 0 | 0 | 4 (7.7%) |
| Pollakiuria | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Respiratory, thoracic, and mediastinal disorders | 23 (44.2%) | 4 (7.7%) | 3 (5.8%) | 0 | 0 | 30 (57.7%) |
| Cough | 4 (7.7%) | 2 (3.8%) | 0 | 0 | 0 | 6 (11.5%) |
| Dyspnea | 12 (23.1%) | 1 (1.9%) | 0 | 0 | 0 | 13 (25.0%) |
| Epistaxis | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Oropharyngeal pain | 5 (9.6%) | 0 | 0 | 0 | 0 | 5 (9.6%) |
| Pneumonia aspiration | 0 | 0 | 2 (3.8%) | 0 | 0 | 2 (3.8%) |
| Rhinorrhea | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Sinus congestion | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Skin and subcutaneous tissue disorders | 11 (21.2%) | 7 (13.5%) | 0 | 0 | 0 | 18 (34.6%) |
| Alopecia | 2 (3.8%) | 4 (7.7%) | 0 | 0 | 0 | 6 (11.5%) |
| Rash | 7 (13.5%) | 2 (3.8%) | 0 | 0 | 0 | 9 (17.3%) |
| Skin Exfoliation | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Vascular disorders | 2 (3.8%) | 5 (9.6%) | 1 (1.9%) | 1 (1.9%) | 0 | 9 (17.3%) |
| Deep vein thrombosis | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Embolism | 0 | 2 (3.8%) | 0 | 0 | 0 | 2 (3.8%) |
| Hypertension | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Hypotension | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| AE . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total . |
|---|---|---|---|---|---|---|
| Blood and lymphatic system disorders | 3 (5.8%) | 9 (17.3%) | 19 (36.5%) | 6 (11.5%) | 0 | 37 (71.2%) |
| Anemia | 2 (3.8%) | 9 (17.3%) | 11 (21.2%) | 0 | 0 | 22 (42.3%) |
| Febrile Neutropenia | 0 | 1 (1.9%) | 6 (11.5%) | 0 | 0 | 7 (13.5%) |
| Leukopenia | 1 (1.9%) | 0 | 0 | 1 (1.9%) | 0 | 2 (3.8%) |
| Lymphopenia | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Neutropenia | 1 (1.9%) | 2 (3.8%) | 5 (9.6%) | 5 (9.6%) | 0 | 13 (25.0%) |
| Thrombocytopenia | 0 | 2 (3.8%) | 0 | 1 (1.9%) | 0 | 3 (5.8%) |
| Cardiac disorders, tachycardia | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 0 | 3 (5.8%) |
| Ear and labyrinth disorders, ear pain | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Eye disorders | 11 (21.2%) | 2 (3.8%) | 0 | 0 | 0 | 13 (25.0%) |
| Dry eye | 6 (11.5%) | 0 | 0 | 0 | 0 | 6 (11.5%) |
| Lacrimation increased | 5 (9.6%) | 1 (1.9%) | 0 | 0 | 0 | 6 (11.5%) |
| Vision blurred | 8 (15.4%) | 1 (1.9%) | 0 | 0 | 0 | 9 (17.3%) |
| Gastrointestinal disorders | 20 (38.5%) | 18 (34.6%) | 8 (15.4%) | 0 | 0 | 46 (88.5%) |
| Abdominal pain | 2 (3.8%) | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 5 (9.6%) |
| Constipation | 18 (34.6%) | 10 (19.2%) | 2 (3.8%) | 0 | 0 | 30 (57.7%) |
| Diarrhea | 9 (17.3%) | 5 (9.6%) | 0 | 0 | 0 | 14 (26.9%) |
| Dyspepsia | 2 (3.8%) | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Gastritis | 0 | 2 (3.8%) | 0 | 0 | 0 | 2 (3.8%) |
| Gastroesophageal reflux disease | 4 (7.7%) | 4 (7.7%) | 1 (1.9%) | 0 | 0 | 9 (17.3%) |
| Nausea | 12 (23.1%) | 10 (19.2%) | 4 (7.7%) | 0 | 0 | 26 (50.0%) |
| Oral pain | 5 (9.6%) | 6 (11.5%) | 1 (1.9%) | 0 | 0 | 12 (23.1%) |
| Stomatitis | 5 (9.6%) | 4 (7.7%) | 2 (3.8%) | 0 | 0 | 11 (21.2%) |
| Vomiting | 6 (11.5%) | 5 (9.6%) | 4 (7.7%) | 0 | 0 | 15 (28.8%) |
| General disorders and administration site conditions | 16 (30.8%) | 23 (44.2%) | 8 (15.4%) | 1 (1.9%) | 0 | 48 (92.3%) |
| Chest pain | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Fatigue | 16 (30.8%) | 19 (36.5%) | 3 (5.8%) | 1 (1.9%) | 0 | 39 (75.0%) |
| Local swelling | 2 (3.8%) | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Mucosal inflammation | 15 (28.8%) | 8 (15.4%) | 4 (7.7%) | 0 | 0 | 27 (51.9%) |
| Edema peripheral | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 0 | 3 (5.8%) |
| Pyrexia | 5 (9.6%) | 4 (7.7%) | 0 | 0 | 0 | 9 (17.3%) |
| Infections and infestations | 7 (13.5%) | 9 (17.3%) | 4 (7.7%) | 1 (1.9%) | 1 (1.9%) | 22 (42.3%) |
| Candida infection | 0 | 3 (5.8%) | 0 | 0 | 0 | 3 (5.8%) |
| Nasopharyngitis | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Pneumonia | 0 | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 2 (3.8%) |
| Upper respiratory tract infection | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Investigations | 9 (17.3%) | 5 (9.6%) | 7 (13.5%) | 5 (9.6%) | 0 | 26 (50.0%) |
| Alanine aminotransferase level increased | 6 (11.5%) | 0 | 2 (3.8%) | 0 | 0 | 8 (15.4%) |
| Aspartate aminotransferase level increased | 5 (9.6%) | 1 (1.9%) | 1 (1.9%) | 1 (1.9%) | 0 | 8 (15.4%) |
| Blood creatinine level increased | 2 (3.8%) | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Hematocrit level decreased | 0 | 2 (3.8%) | 0 | 0 | 0 | 2 (3.8%) |
| Lymphocyte count decreased | 1 (1.9%) | 1 (1.9%) | 2 (3.8%) | 1 (1.9%) | 0 | 5 (9.6%) |
| Neutrophil count decreased | 0 | 0 | 2 (3.8%) | 3 (5.8%) | 0 | 5 (9.6%) |
| Platelet count decreased | 3 (5.8%) | 3 (5.8%) | 0 | 1 (1.9%) | 0 | 7 (13.5%) |
| Weight decreased | 5 (9.6%) | 0 | 0 | 0 | 0 | 5 (9.6%) |
| White blood cell count decreased | 0 | 3 (5.8%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Metabolism and nutrition disorders | 15 (28.8%) | 5 (9.6%) | 3 (5.8%) | 0 | 0 | 23 (44.2%) |
| Decreased appetite | 10 (19.2%) | 2 (3.8%) | 0 | 0 | 0 | 12 (23.1%) |
| Dehydration | 1 (1.9%) | 3 (5.8%) | 1 (1.9%) | 0 | 0 | 5 (9.6%) |
| Hyperglycemia | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Hyperuricemia | 4 (7.7%) | 0 | 0 | 0 | 0 | 4 (7.7%) |
| Hypokalemia | 5 (9.6%) | 1 (1.9%) | 0 | 0 | 0 | 6 (11.5%) |
| Hypomagnesemia | 4 (7.7%) | 0 | 0 | 0 | 0 | 4 (7.7%) |
| Musculoskeletal and connective tissue disorders | 10 (19.2%) | 8 (15.4%) | 1 (1.9%) | 1 (1.9%) | 0 | 20 (38.5%) |
| Arthralgia | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Back pain | 1 (1.9%) | 2 (3.8%) | 1 (1.9%) | 0 | 0 | 4 (7.7%) |
| Bone pain | 2 (3.8%) | 3 (5.8%) | 0 | 0 | 0 | 5 (9.6%) |
| Muscle spasms | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Myalgia | 5 (9.6%) | 3 (5.8%) | 0 | 0 | 0 | 8 (15.4%) |
| Nervous system disorders | 22 (42.3%) | 6 (11.5%) | 1 (1.9%) | 0 | 0 | 29 (55.8%) |
| Dizziness | 10 (19.2%) | 3 (5.8%) | 0 | 0 | 0 | 13 (25.0%) |
| Headache | 5 (9.6%) | 0 | 1 (1.9%) | 0 | 0 | 6 (11.5%) |
| Hypoesthesia | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Memory impairment | 5 (9.6%) | 2 (3.8%) | 0 | 0 | 0 | 7 (13.5%) |
| Neuropathy peripheral | 9 (17.3%) | 2 (3.8%) | 0 | 0 | 0 | 11 (21.2%) |
| Peripheral sensory neuropathy | 6 (11.5%) | 1 (1.9%) | 0 | 0 | 0 | 7 (13.5%) |
| Psychiatric disorders | 11 (21.2%) | 4 (7.7%) | 0 | 0 | 0 | 15 (28.8%) |
| Anxiety | 1 (1.9%) | 2 (3.8%) | 0 | 0 | 0 | 3 (5.8%) |
| Depression | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Insomnia | 8 (15.4%) | 2 (3.8%) | 0 | 0 | 0 | 10 (19.2%) |
| Renal and urinary disorders | 7 (13.5%) | 1 (1.9%) | 0 | 0 | 0 | 8 (15.4%) |
| Dysuria | 4 (7.7%) | 0 | 0 | 0 | 0 | 4 (7.7%) |
| Pollakiuria | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Respiratory, thoracic, and mediastinal disorders | 23 (44.2%) | 4 (7.7%) | 3 (5.8%) | 0 | 0 | 30 (57.7%) |
| Cough | 4 (7.7%) | 2 (3.8%) | 0 | 0 | 0 | 6 (11.5%) |
| Dyspnea | 12 (23.1%) | 1 (1.9%) | 0 | 0 | 0 | 13 (25.0%) |
| Epistaxis | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Oropharyngeal pain | 5 (9.6%) | 0 | 0 | 0 | 0 | 5 (9.6%) |
| Pneumonia aspiration | 0 | 0 | 2 (3.8%) | 0 | 0 | 2 (3.8%) |
| Rhinorrhea | 3 (5.8%) | 0 | 0 | 0 | 0 | 3 (5.8%) |
| Sinus congestion | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Skin and subcutaneous tissue disorders | 11 (21.2%) | 7 (13.5%) | 0 | 0 | 0 | 18 (34.6%) |
| Alopecia | 2 (3.8%) | 4 (7.7%) | 0 | 0 | 0 | 6 (11.5%) |
| Rash | 7 (13.5%) | 2 (3.8%) | 0 | 0 | 0 | 9 (17.3%) |
| Skin Exfoliation | 2 (3.8%) | 0 | 0 | 0 | 0 | 2 (3.8%) |
| Vascular disorders | 2 (3.8%) | 5 (9.6%) | 1 (1.9%) | 1 (1.9%) | 0 | 9 (17.3%) |
| Deep vein thrombosis | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Embolism | 0 | 2 (3.8%) | 0 | 0 | 0 | 2 (3.8%) |
| Hypertension | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |
| Hypotension | 1 (1.9%) | 1 (1.9%) | 0 | 0 | 0 | 2 (3.8%) |