Statement: There were 2 cases of severe back pain observed in the primary trial.
Primary_evidence: Adverse Events 1:   Total: 3/25 (12.00%)   Anemia 0/25 (0.00%)   Sinus tachycardia 0/25 (0.00%)   Pericardial effusion 1/25 (4.00%)   Gastrointestinal disorders - Other, specify -stomatitis) 0/25 (0.00%)   Vomiting 1/25 (4.00%)   Fever 0/25 (0.00%)   Injection site reaction 1/25 (4.00%)   Catheter related infection 0/25 (0.00%)   Activated partial thromboplastin time prolonged 0/25 (0.00%) Adverse Events 2:   Total: 2/23 (8.70%)   Anemia 1/23 (4.35%)   Sinus tachycardia 1/23 (4.35%)   Pericardial effusion 0/23 (0.00%)   Gastrointestinal disorders - Other, specify -stomatitis) 1/23 (4.35%)   Vomiting 0/23 (0.00%)   Fever 1/23 (4.35%)   Injection site reaction 1/23 (4.35%)   Catheter related infection 1/23 (4.35%)   Activated partial thromboplastin time prolonged 1/23 (4.35%)