Table 2.
ARM1/BEV-NAIVE (n=73) Grade | ARM2/BEV-NAIVE (n=73) Grade | ARM1/BEV-FAILURE (n=32) Grade | ARM2/BEV-FAILURE (n=37) Grade | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
System Organ Class | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 |
Investigations | 9 | 11 | 26 | 7 | 0 | 20 | 22 | 16 | 2 | 0 | 3 | 6 | 7 | 7 | 0 | 13 | 5 | 6 | 2 | 0 |
CD4 lymphocytes decreased | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Lymphocyte count decreased | 2 | 5 | 23 | 1 | 0 | 4 | 15 | 11 | 2 | 0 | 1 | 6 | 3 | 3 | 0 | 2 | 5 | 5 | 1 | 0 |
Neutrophil count decreased | 4 | 11 | 9 | 5 | 0 | 6 | 6 | 3 | 0 | 0 | 2 | 2 | 2 | 2 | 0 | 1 | 0 | 2 | 1 | 0 |
Platelet count decreased | 23 | 6 | 9 | 3 | 0 | 32 | 10 | 6 | 0 | 0 | 10 | 3 | 4 | 4 | 0 | 18 | 2 | 1 | 1 | 0 |
Blood and lymphatic system disorders | 20 | 3 | 1 | 0 | 0 | 23 | 4 | 0 | 0 | 0 | 7 | 1 | 1 | 1 | 0 | 7 | 3 | 1 | 0 | 0 |
Cardiac disorders | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Ear and labyrinth disorders | 1 | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Endocrine disorders | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Eye disorders | 5 | 2 | 0 | 0 | 0 | 4 | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 3 | 1 | 0 | 0 |
Gastrointestinal disorders | 20 | 17 | 1 | 0 | 0 | 15 | 18 | 3 | 1 | 0 | 8 | 7 | 3 | 0 | 0 | 10 | 4 | 1 | 0 | 0 |
General disorders/administration site conditions | 19 | 16 | 2 | 0 | 2 | 23 | 14 | 4 | 0 | 1 | 7 | 9 | 2 | 0 | 0 | 9 | 10 | 3 | 0 | 0 |
Immune system disorders | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Infections and infestations | 1 | 3 | 5 | 0 | 0 | 0 | 9 | 3 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 4 | 1 | 0 | 0 |
Injury, poisoning and procedural complications | 3 | 4 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
Metabolism and nutrition disorders | 17 | 7 | 3 | 0 | 0 | 20 | 8 | 5 | 0 | 0 | 8 | 5 | 3 | 1 | 0 | 9 | 3 | 3 | 2 | 0 |
Musculoskeletal and connective tissue disorders | 9 | 8 | 4 | 0 | 0 | 8 | 8 | 4 | 0 | 0 | 4 | 7 | 6 | 0 | 0 | 3 | 7 | 4 | 0 | 0 |
Neoplasms benign, malignant and unspecified | 0 | 0 | 1 | 0 | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 2 | 0 | 3 |
Nervous system disorders | 23 | 24 | 5 | 4 | 1 | 19 | 19 | 13 | 2 | 0 | 8 | 10 | 4 | 0 | 0 | 8 | 6 | 7 | 1 | 1 |
Psychiatric disorders | 10 | 8 | 2 | 0 | 0 | 7 | 10 | 4 | 0 | 0 | 8 | 3 | 2 | 0 | 0 | 4 | 8 | 0 | 0 | 0 |
Renal and urinary disorders | 5 | 2 | 0 | 0 | 0 | 5 | 2 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
Reproductive system and breast disorders | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Respiratory, thoracic and mediastinal disorders | 4 | 2 | 1 | 0 | 1 | 9 | 4 | 0 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 1 | 4 | 0 | 0 | 0 |
Skin and subcutaneous tissue disorders | 10 | 3 | 0 | 0 | 0 | 6 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 |
Social circumstances | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Vascular disorders | 2 | 7 | 0 | 1 | 0 | 1 | 5 | 6 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
Includes adverse events where relationship to protocol treatment is missing.
Adverse events were graded with CTCAE version 4. (Specific toxicities types in italics).