Study: NCT02766465

Adverse event: PRES
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: TONIC CLONIC SEIZURE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: EPILEPTIC SEIZURES
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: ACUTE SUBARACHNOID HEMORRHAGE
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: GRADE 4 MUCOSITIS ORAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: HYPERTENSION MANAGEMENT
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: POSTERIOR REVERSIBLE ENCEPHALOPATHY
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pyelonephritis acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Septic shock
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the second year following biologic assignment
Frequency: 1 affected / 28 at risk

Adverse event: Significant cerebrovascular event
Serious: no
Organ System: Nervous system disorders
Notes: During the second year following biologic assignment
Frequency: 1 affected / 28 at risk

Adverse event: Renal function compromise
Serious: no
Organ System: Renal and urinary disorders
Notes: During the second year following biologic assignment
Frequency: 3 affected / 28 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the second year following biologic assignment
Frequency: 1 affected / 28 at risk

Adverse event: Vaso-occlusive pain with hospitalization or parenteral opioid drugs in outpatient setting
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: During the second year following biologic assignment
Frequency: 2 affected / 28 at risk

Adverse event: Bacterial, Fungal, and Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 28 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the first year following biologic assignment
Frequency: 1 affected / 28 at risk

Adverse event: Significant cerebrovascular event
Serious: no
Organ System: Nervous system disorders
Notes: During the first year following biologic assignment
Frequency: 5 affected / 28 at risk

Adverse event: Renal function compromise
Serious: no
Organ System: Renal and urinary disorders
Notes: During the first year following biologic assignment
Frequency: 5 affected / 28 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the first year following biologic assignment
Frequency: 4 affected / 28 at risk

Adverse event: Leg ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the first year following biologic assignment
Frequency: 1 affected / 28 at risk

Adverse event: Acute chest syndrome with hospitalization
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the first year following biologic assignment
Frequency: 3 affected / 28 at risk

Adverse event: Vaso-occlusive pain with hospitalization or parenteral opioid drugs in outpatient setting
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: During the first year following biologic assignment
Frequency: 10 affected / 28 at risk

Adverse event: ACCIDENTAL DRUG OVERDOSE
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: SICKLE CELL CRISIS AND BIPAP
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 2 affected / 85 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Acute chest syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 85 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: CARDIAC ARRES
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: End stage renal disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 85 at risk

Adverse event: ACUTE CEREBROVASCULAR ACCIDENT
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: RESPIRATORY DISTRES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the second year following biologic assignment
Frequency: 4 affected / 85 at risk

Adverse event: Significant cerebrovascular event
Serious: no
Organ System: Nervous system disorders
Notes: During the second year following biologic assignment
Frequency: 5 affected / 85 at risk

Adverse event: Renal function compromise
Serious: no
Organ System: Renal and urinary disorders
Notes: During the second year following biologic assignment
Frequency: 6 affected / 85 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the second year following biologic assignment
Frequency: 6 affected / 85 at risk

Adverse event: Leg ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the second year following biologic assignment
Frequency: 1 affected / 85 at risk

Adverse event: Acute chest syndrome with hospitalization
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the second year following biologic assignment
Frequency: 8 affected / 85 at risk

Adverse event: Vaso-occlusive pain with hospitalization or parenteral opioid drugs in outpatient setting
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: During the second year following biologic assignment
Frequency: 59 affected / 85 at risk

Adverse event: Bacterial, Fungal, and Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 85 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the first year following biologic assignment
Frequency: 4 affected / 85 at risk

Adverse event: Significant cerebrovascular event
Serious: no
Organ System: Nervous system disorders
Notes: During the first year following biologic assignment
Frequency: 3 affected / 85 at risk

Adverse event: Renal function compromise
Serious: no
Organ System: Renal and urinary disorders
Notes: During the first year following biologic assignment
Frequency: 11 affected / 85 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the first year following biologic assignment
Frequency: 10 affected / 85 at risk

Adverse event: Leg ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: During the first year following biologic assignment
Frequency: 3 affected / 85 at risk

Adverse event: Acute chest syndrome with hospitalization
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the first year following biologic assignment
Frequency: 12 affected / 85 at risk

Adverse event: Vaso-occlusive pain with hospitalization or parenteral opioid drugs in outpatient setting
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: During the first year following biologic assignment
Frequency: 65 affected / 85 at risk