Table 2.
Number of Patients with an Adverse Event by System Organ Class and Grade. Any Relationship to Protocol Treatment
| 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).