TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00580229

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 50 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 50 at risk

Adverse event: fibromyalgia flare
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk
Study: NCT00580333

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 36 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 51 at risk
Study: NCT00580398

Adverse event: Psychiatric Instability
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient admitted for psychiatric evaluation for anxiety. At admission, patient was taking varenicline for 6 weeks per study protocol. Because varenicline can cause psychiatric side effects, event reported as possibly related to study medication.
Frequency: 1 affected / 32 at risk
Study: NCT00580502

Adverse event: Band revision/replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 14 affected / 50 at risk

Adverse event: Port revision/replacement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 50 at risk
Study: NCT00580645

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 7 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fast Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fast Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 20 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fast Heartbeat
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk
Study: NCT00580671

Adverse event: Residential Treatment for Substance Use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 51 at risk

Adverse event: Hospitatlization or Residential Treatment for Mental Health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 51 at risk

Adverse event: Boot Camp, Detention, Incarceration
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Arrested
Serious: no
Organ System: General disorders
Notes: Arrest not resulting in boot camp, detention, or incarceration
Frequency: 2 affected / 51 at risk

Adverse event: Running Away
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Expelled from School
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Residential Treatment for Substance Use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hospitatlization or Residential Treatment for Mental Health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Boot Camp, Detention, Incarceration
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Arrested
Serious: no
Organ System: General disorders
Notes: Arrest not resulting in boot camp, detention, or incarceration
Frequency: 3 affected / 51 at risk

Adverse event: Running Away
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Expelled from School
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Dropped Out of School
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Residential Treatment for Substance Use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hospitatlization or Residential Treatment for Mental Health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Boot Camp, Detention, Incarceration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Arrested
Serious: no
Organ System: General disorders
Notes: Arrest not resulting in boot camp, detention, or incarceration
Frequency: 1 affected / 51 at risk

Adverse event: Expelled from School
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: DCFS Report
Serious: no
Organ System: General disorders
Notes: Report made to the department of children and family services (DCFS)
Frequency: 1 affected / 51 at risk
Study: NCT00580788

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3 at risk

Adverse event: Migraine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3 at risk

Adverse event: lightheaded
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 2 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 2 at risk
Study: NCT00581009

Adverse event: brief hypomanic switch
Serious: no
Organ System: Psychiatric disorders
Notes: brief hypomanic period including pressured speech and elevated mood
Frequency: 2 affected / 32 at risk
Study: NCT00581061

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk
Study: NCT00581113

Adverse event: Neurology - Other (Disease Progression)
Serious: yes
Organ System: Nervous system disorders
Notes: Attributed to disease
Frequency: 1 affected / 4 at risk

Adverse event: Cognitive disturbance - New Brain Mets
Serious: yes
Organ System: Nervous system disorders
Notes: Attributed to disease
Frequency: 1 affected / 4 at risk
Study: NCT00581308

Adverse event: Cardiac Overall
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 215 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Embolization (post-procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 215 at risk

Adverse event: Valvular Damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Device (HELEX Septal Occluder) Overall
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 215 at risk

Adverse event: Device removal due to fracture
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 215 at risk

Adverse event: Device removal-other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Neurologic Overall
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Other - Neurologic complication
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Headache (Minor)
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 215 at risk

Adverse event: Arrhythmia (Minor)
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 215 at risk

Adverse event: Palipations (Minor)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 215 at risk

Adverse event: Fracture-wire frame (Minor)
Serious: no
Organ System: Investigations
Frequency: 19 affected / 215 at risk
Study: NCT00581854

Adverse event: Infection with febrile neutropenia, Gr 3
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Neutropenic Fever Gr 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 22 at risk

Adverse event: Atrial fibrillation gr 3, dyspnea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: perionitis, gr 5
Serious: yes
Organ System: Infections and infestations
Notes: bowel infarction resulting in septicemia
Frequency: 1 affected / 22 at risk

Adverse event: psuedomonas sepsis, gr 5
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Hyponatremia, gr 3
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Chronic Heart Failure, gr 5
Serious: yes
Organ System: Cardiac disorders
Notes: Pt also experienced sinus tachycardia, hypotension.
Frequency: 1 affected / 22 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 19 events of gr 3, 41 events of Gr 4 = 59 events out of 104 cycles of therapy adminsitered.
Frequency: 18 affected / 22 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Events are total occurrences out of 104 cycles of therapy adminsitered across subjects
Frequency: 4 affected / 22 at risk

Adverse event: infection with neutropenia
Serious: no
Organ System: Infections and infestations
Notes: total is # of grade 3 and 4 events in 104 cycles of therapy administered across 22 subjects.
Frequency: 6 affected / 22 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 22 cases of grade 3, 2 cases of gr 4 thrombocytopenia out of 104 cycles of therapy administered.
Frequency: 8 affected / 22 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: 11 cases of grade 3, 1 case of gr 4 anemia out of 104 cycles of therapy administered.
Frequency: 8 affected / 22 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 9 cases of gr 3 hyperglycemia out of 104 cycles of therapy administered.
Frequency: 4 affected / 22 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Notes: 3 cases of gr 3 dehydration out of 104 cycles of therapy administered.
Frequency: 1 affected / 22 at risk
Study: NCT00581867

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: An individual died 38 days after having one dose of intranasal saline (placebo) during the washout period due to pulmonary embolism and prior to returning for intranasal insulin. The death was considered unrelated to the intervention.
Frequency: 1 affected / 29 at risk
Study: NCT00581971

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Radiation Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fever (in absence of Neutropenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 30 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 30 at risk

Adverse event: Radiation Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk
Study: NCT00582010

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk
Study: NCT00582205

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Resulting in dose delays
Frequency: 6 affected / 21 at risk
Study: NCT00582361

Adverse event: Infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Required Flap Coverage
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Amputation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk
Study: NCT00582400

Adverse event: Diarrhoea haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Blood in stool
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: bilateral extremity edema
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain and swelling
Frequency: 1 affected / 9 at risk

Adverse event: abdominal edema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: bilateral lower extremity weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT00582491

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Heart Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Back/Neck Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT00582608

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hemoglobin (Hgb)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk
Study: NCT00582712

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death not associated with CTCAE term - Death was unrelated to study.
Frequency: 3 affected / 5 at risk

Adverse event: Grade 3 fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Grade 3 speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Grade 2 dizziness (vertigo)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT00582816

Adverse event: Grade 3 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 9 at risk

Adverse event: Grade 3 anorexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 9 at risk

Adverse event: Grade 3 diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Grade 3 GVHD
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Grade 2 seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Grade 4 engraftment failure possibly from CMV riemia or inadequate stem cell dose
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 4 engraftment failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 3 dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 2 diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 1 fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 3 fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 2 acute GVHD
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 3 skin GVHD
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 4 graft rejection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 3 hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 4 infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Grade 1 leukoencephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Grade 2 pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk