TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00765856

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sickle cell anaemia with crisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Increased alanine aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Increased aspartate aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 24 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pouchitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk
Study: NCT00765895

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: cardiac event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nervous system
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 65 at risk

Adverse event: gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 65 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: renal and urinary events
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 65 at risk

Adverse event: ocular events
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 65 at risk

Adverse event: swelling of hands and feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nervous system
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 65 at risk

Adverse event: gastrointestinal events
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 65 at risk

Adverse event: cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 65 at risk

Adverse event: psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 65 at risk

Adverse event: endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 65 at risk

Adverse event: weight gain/loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 65 at risk

Adverse event: general disorders
Serious: no
Organ System: General disorders
Notes: insomnia
Frequency: 3 affected / 65 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 65 at risk
Study: NCT00765947

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk
Study: NCT00766038

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Patients with TBI are at high risk for post-traumatic seizures. Seizure in participants in this study are an expected adverse event
Frequency: 2 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Elective surgery
Serious: no
Organ System: General disorders
Frequency: 6 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Patients with TBI are at high risk for post-traumatic seizures. Seizure in participants in this study are an expected adverse event
Frequency: 2 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Elective surgery
Serious: no
Organ System: General disorders
Frequency: 4 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 32 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 32 at risk
Study: NCT00766090

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 187 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 140 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 142 at risk
Study: NCT00766116

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: fever/pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Gram (-) Rods
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: nausea, vomiting, abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hospitalized with syncopal event with intraventricular hemorrhage.
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension second to Mylotarg infusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Infection documented/ relapsed AML
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Refractory platlets
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 38 affected / 50 at risk

Adverse event: Gram Positive Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 50 at risk

Adverse event: Gram Negative Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 50 at risk

Adverse event: Abnormalities in liver function tests
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 50 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: SIRS/Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 50 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Electrolyte abnormalities
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 50 at risk
Study: NCT00766363

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk
Study: NCT00766376

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 26 affected / 124 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 123 affected / 124 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 124 affected / 124 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 98 affected / 124 at risk

Adverse event: Oozing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 71 affected / 124 at risk

Adverse event: Skin Texture Changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 9 affected / 124 at risk

Adverse event: Bronzing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 67 affected / 124 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 55 affected / 124 at risk

Adverse event: Shrinkage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 9 affected / 124 at risk

Adverse event: Increased Sensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 40 affected / 124 at risk

Adverse event: Crusting
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 55 affected / 124 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Transient side effects all resolved.
Frequency: 35 affected / 124 at risk
Study: NCT00766415

Adverse event: Hypoxia After Bronchoscopy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk
Study: NCT00766597

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Blood bicarbonate abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 4 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rhonchi
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk
Study: NCT00766636

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT00767039

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death before NICU discharge
Frequency: 5 affected / 27 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Stage 2 Necrotizing enterocolitis
Frequency: 4 affected / 27 at risk

Adverse event: Severe Intraventricular Hemorrahge (Grade 3-4)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Significant Pulmonary Hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary hemorrhage associated with an increase in respiratory support
Frequency: 3 affected / 27 at risk

Adverse event: ROP Stage II-IV
Serious: yes
Organ System: Eye disorders
Notes: Retinopathy of Prematurity at threshold, treated with Laser
Frequency: 10 affected / 23 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen requirement at 36 weeks Post menstrual age in infants surviving to 36+ weeks.
Frequency: 11 affected / 22 at risk

Adverse event: Patent ductus arteriosus repair
Serious: no
Organ System: Cardiac disorders
Notes: PDA requiring surgical ligation
Frequency: 7 affected / 25 at risk

Adverse event: Pulmonary Air Leak
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary air leak including: pulmonary interstitial emphysema, pneumothorax, pneumatocele
Frequency: 4 affected / 27 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death before NICU discharge
Frequency: 2 affected / 25 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Stage 2 Necrotizing enterocolitis
Frequency: 4 affected / 25 at risk

Adverse event: Severe Intraventricular Hemorrahge (Grade 3-4)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Significant Pulmonary Hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary hemorrhage associated with an increase in respiratory support
Frequency: 1 affected / 25 at risk

Adverse event: ROP Stage II-IV
Serious: yes
Organ System: Eye disorders
Notes: Retinopathy of Prematurity at threshold, treated with Laser
Frequency: 7 affected / 24 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen requirement at 36 weeks Post menstrual age in infants surviving to 36+ weeks.
Frequency: 8 affected / 23 at risk

Adverse event: Patent ductus arteriosus repair
Serious: no
Organ System: Cardiac disorders
Notes: PDA requiring surgical ligation
Frequency: 4 affected / 25 at risk
Study: NCT00767325

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Pulmonary fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 104 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 104 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 104 at risk