TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00427661

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 21 year old female patient developed complications related to sickle cell disease associated progressive pulmonary arterial hypertension and died 10 months post BMT.
Frequency: 1 affected / 8 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: Seizure day+11 secondary to low level of phenytoin

(Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270.)
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache day +1-+4, post transplant, requiring analgesics (Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270)
Frequency: 1 affected / 8 at risk

Adverse event: Line related bacteremia
Serious: no
Organ System: Infections and infestations
Notes: line related bacteremia with Rhizobium radiobactor d100

(Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270.
Frequency: 1 affected / 8 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild pancreatitis Day +109

(Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270)
Frequency: 1 affected / 8 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Dermatomal herpes zoster Parainfluenza A infection

(Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270)
Frequency: 1 affected / 8 at risk

Adverse event: Line related bacteremia
Serious: no
Organ System: Infections and infestations
Notes: Line related bacteremia d244

(Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270)
Frequency: 1 affected / 8 at risk

Adverse event: Poor oral intake
Serious: no
Organ System: Gastrointestinal disorders
Notes: Required transient parenteral alimentation

(Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270)
Frequency: 2 affected / 8 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Hemoglobinuria immediately following stem cell transplant the resolved within 48 hours (Krishnamurti et al., 2008. Biol Blood Marrow Transplant 14:1270)
Frequency: 1 affected / 8 at risk
Study: NCT00427700

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 1 affected / 42 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 42 at risk
Study: NCT00427960

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk
Study: NCT00428077

Adverse event: Acute Viral Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: In one patient a grade 3 GI AE (acute gastroenteritis) occurred and led to hospitalization. This event was felt to be unrelated to study drug.
Frequency: 1 affected / 4 at risk

Adverse event: Injection site induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All patients developed grade 1-2 injections site indurations, which slowly resolved over several months.
Frequency: 4 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Patients experienced grade 1-2 fatigue in association with the injection of GM-CSF. This is an established side effect of the agent.
Frequency: 3 affected / 4 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: One patient was diagnosed with grade 2 cataracts while on study. Given that this is common in the patient's age group, it is unlikely to be related to study medication.
Frequency: 1 affected / 4 at risk
Study: NCT00428116

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 21 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 21 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 21 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 21 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 21 at risk
Study: NCT00428922

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 26 at risk

Adverse event: Neutropenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 26 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 26 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 26 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 26 at risk

Adverse event: decreased LVEF
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 26 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 26 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 26 at risk

Adverse event: Vision changes
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 26 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 26 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 26 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 26 at risk

Adverse event: Increased lacrimation
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 26 at risk
Study: NCT00428974

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urine oxalate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT00429026

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 40 at risk
Study: NCT00429104

Adverse event: Pyrexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 17 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 17 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Sore finger/toes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Rash at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 17 at risk

Adverse event: Itchy hands/feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk
Study: NCT00429143

Adverse event: Cytokine release syndrome/acute infusion reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Death - Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Liver dysfunction/failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hepatic failure
Frequency: 1 affected / 27 at risk

Adverse event: Death - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Opportunistic infection associated with >=Grade 2 Lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 27 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Renal/Genitourinary - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Constitutional Symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Death - Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 27 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 27 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 27 at risk
Study: NCT00429169

Adverse event: Suicide attempt by acetaminophen overdose
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Patient admitted to hospital and treated. No serious medical sequelae resulted.
Frequency: 1 affected / 36 at risk

Adverse event: Increased suicidal thoughts causing admission to hospital
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Increased suicidal thoughts causing admission to hospital
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk
Study: NCT00429182

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 32 at risk
Study: NCT00429416

Adverse event: Diarrhoea
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Bone marrow cellularity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Pancyptopenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 14 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Progressive disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Fevers
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rash
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Prostatic obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Opportunistic infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Bladder obstruction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Renal failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk
Study: NCT00429494

Adverse event: Menopausal side effects
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Menopausal side effects, including hot flushing, vaginal dryness, and mood swings
Frequency: 9 affected / 59 at risk
Study: NCT00429507

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 12 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 12 at risk
Study: NCT00429572

Adverse event: Diarhhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 19 at risk
Study: NCT00429585

Adverse event: Patient fall
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient fell post op day 1 with catastrophic failure of proximal fixation requiring revision surgery
Frequency: 1 affected / 52 at risk

Adverse event: Fracture
Serious: yes
Organ System: Surgical and medical procedures
Notes: Extraarticular pilon fracture at distal end of nail requiring orif; Non displaced Dist.Fibula Fx
Frequency: 1 affected / 52 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Over 1 yr since study enrollment. Patient has osteoporosis contralateral distal femur fracture after low energy fall.
Frequency: 1 affected / 52 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Multitrauma/Stroke/Intracranial Hypertension
Frequency: 1 affected / 52 at risk

Adverse event: Painful Implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 52 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 52 at risk

Adverse event: Nonunion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 52 at risk

Adverse event: Malunion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 52 at risk

Adverse event: Wound Breakdown Right Proximal Tibia Surgical Site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 52 at risk

Adverse event: Anterior compartment not functional
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Delayed Union
Serious: no
Organ System: Surgical and medical procedures
Notes: delayed fracture healing
Frequency: 1 affected / 52 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 52 at risk

Adverse event: Fracture
Serious: yes
Organ System: Surgical and medical procedures
Notes: Extraarticular pilon fracture at distal end of nail requiring orif; Non displaced Dist.Fibula Fx
Frequency: 1 affected / 47 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ASPIRATION PNEUMONIA
Frequency: 1 affected / 47 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Nonunion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 47 at risk

Adverse event: Malunion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 47 at risk

Adverse event: Peripheral nerve injury
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 47 at risk