Table 2 Investigator-assessed primary cause of death by MedDRA SOC: 26 April 2013 (ITT population)
SOC | n (%) patients | |
|---|---|---|
| Â | LEN (N=225) | CHB (N=225) |
Deaths | 36 (16.0) | 25 (11.1) |
General disorders and administration site conditions | ||
 Death | 4 (1.8) | 3 (1.3) |
 Disease progression | 3 (1.3) | 2 (0.9) |
 Multi-organ failure | 3 (1.3) | 1 (0.4) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | ||
 Chronic lymphocytic leukemia | 4 (1.8) | 5 (2.2) |
 Refractory chronic lymphocytic leukemia | 0 (0.0) | 1 (0.4) |
 Hodgkin lymphoma | 1 (0.4) | 0 (0.0) |
 Metastatic small intestine carcinoma | 1 (0.4) | 0 (0.0) |
Cardiac disorders | ||
 Cardiac arrest | 3 (1.3) | 0 (0.0) |
 Cardiopulmonary failure | 2 (0.9) | 0 (0.0) |
 Cardiac failure | 1 (0.4) | 3 (1.3) |
 Pericardial effusion | 1 (0.4) | 0 (0.0) |
 Myocardial infarction | 0 (0.0) | 1 (0.4) |
Infections and infestations | ||
 Pneumonia | 5 (2.2) | 3 (1.3) |
 Respiratory tract infection | 1 (0.4) | 0 (0.0) |
 Sepsis | 0 (0.0) | 1 (0.4) |
Respiratory, thoracic and mediastinal disorders | ||
 Respiratory failure | 1 (0.4) | 0 (0.0) |
 Acute respiratory failure | 0 (0.0) | 1 (0.4) |
 Respiratory distress | 0 (0.0) | 1 (0.4) |
Blood and lymphatic system disorders | ||
 Autoimmune hemolytic anemia | 1 (0.4) | 1 (0.4) |
Gastrointestinal disorders | ||
 Lower gastrointestinal hemorrhage | 1 (0.4) | 0 (0.0) |
Metabolism and nutrition disorders | ||
 Tumor lysis syndrome | 1 (0.4) | 0 (0.0) |
Nervous system disorders | ||
 Intracranial hemorrhage | 1 (0.4) | 0 (0.0) |
Psychiatric disorders | ||
 Suicide | 1 (0.4) | 0 (0.0) |
Renal and urinary disorders | ||
 Renal failure | 1 (0.4) | 0 (0.0) |
Injury, poisoning and procedural complications | ||
 Post-procedural hemorrhage | 0 (0.0) | 1 (0.4) |
 Skull fracture | 0 (0.0) | 1 (0.4) |
