TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01122381

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1, mild
Frequency: 1 affected / 1 at risk
Study: NCT01122394

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Broken bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Torn Ligament
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Bone/Muscle injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 66 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 74 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Broken bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 74 at risk

Adverse event: Torn Ligament
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bone/Muscle injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 74 at risk
Study: NCT01122511

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk
Study: NCT01122576

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 52 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: Severe central retinal vein occlusion, remained unresolved at the end of the study.
Frequency: 1 affected / 25 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 50 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Increased Intraocular Pressure (IOP)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 50 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Mild vitreous hemorrhage, resolved in 38 days
Frequency: 1 affected / 23 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Notes: Severe ongoing pulmonary embolism at visit 3
Frequency: 1 affected / 23 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: moderate pyelonephritis which was resolved in 12 days
Frequency: 1 affected / 23 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 46 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 46 at risk
Study: NCT01122680

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk
Study: NCT01122849

Adverse event: Nasal scab secondary to strip removal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk
Study: NCT01122862

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk
Study: NCT01122901

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 40 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 40 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 at risk

Adverse event: platelet count decrease
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: white blood cell decrease
Serious: no
Organ System: Investigations
Frequency: 3 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: platelet count decrease
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: white blood cell decrease
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk
Study: NCT01123070

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

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

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Sideroblastic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk
Study: NCT01123200

Adverse event: Unexpected wheelchair movement
Serious: no
Organ System: Product Issues
Notes: After the BCI was shut down and disconnected, the wheelchair reportedly moved without the user operating the controls. The movement was brief and no injury occurred.
Frequency: 1 affected / 1 at risk
Study: NCT01123382

Adverse event: Headache, hospitalization
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Electrode dislodgement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Retained Electrode Fragment
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: Pruritus at electrode or bandage site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 13 at risk

Adverse event: Pain after electrode implantation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Chest pain, hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk
Study: NCT01123395

Adverse event: Headache ∗
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk
Study: NCT01123642

Adverse event: hospitalized for suicidal ideation/attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 309 at risk

Adverse event: hospitalized for homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 309 at risk

Adverse event: Hospitalized for mental health
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 309 at risk

Adverse event: Hospitalized for physical condition
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 309 at risk

Adverse event: ER for physical condition
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 309 at risk

Adverse event: Visit to ER for chest pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 309 at risk

Adverse event: Detained in jail
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 309 at risk
Study: NCT01123655

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hospitalized
Frequency: 1 affected / 14 at risk

Adverse event: malaise, itching
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: flu-GI virus
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 14 at risk

Adverse event: RA flare
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Burning rash on cheek
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Injection site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: pet bite
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: l4-l5 decompression
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 14 at risk

Adverse event: broken tooth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: lesion removed from ear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Inguinal hernia repair
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 14 at risk

Adverse event: lips tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: lightheaded with ringing in ears
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: atypical chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: DJD worse
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 8 at risk
Study: NCT01123941

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 25 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 25 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 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: SPONTANEOUS PNEUMOTHORAX RIGHT SIDE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 25 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: muscoloskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk
Study: NCT01123980

Adverse event: Adrenal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 261 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 261 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 261 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 260 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 260 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 260 at risk
Study: NCT01124045

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Notes: Not related. Hospital admission was required for procedures involving surgery/anesthesia of certain infants.
Frequency: 6 affected / 39 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: Related
Frequency: 1 affected / 39 at risk

Adverse event: Cataract cortical
Serious: yes
Organ System: Immune system disorders
Notes: Not related
Frequency: 1 affected / 39 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 39 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 39 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 39 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 39 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 39 at risk

Adverse event: Cataract operation (non-study eye)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 39 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Notes: Not related. Hospital admission was required for procedures involving surgery/anesthesia of certain infants.
Frequency: 10 affected / 40 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not related
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Cataract operation (non-study eye)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 40 at risk
Study: NCT01124162

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 7 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 80 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk
Study: NCT01124175

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 80 at risk
Study: NCT01124305

Adverse event: Knee stiff
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Manipulation under anesthesia for limited range of motion
Frequency: 1 affected / 26 at risk
Study: NCT01124916

Adverse event: Illiac Vein Injury
Serious: no
Organ System: Surgical and medical procedures
Notes: Left Iliac Vein Injury occurred at the time of the presacral dissection
Frequency: 1 affected / 38 at risk

Adverse event: Incarcerated hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tissue granulation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Granulation of tissue was noted in the posterior midline of the vagina
Frequency: 3 affected / 38 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Mallory-Weiss tear
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Intraoperative cystotomy
Serious: no
Organ System: Surgical and medical procedures
Notes: While passing the trocar, an Intraoperative Cystotomy was encountered. This was immediately identified by Cystoscopy and removed
Frequency: 1 affected / 38 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Mesh Exposure
Serious: no
Organ System: Surgical and medical procedures
Notes: Suburethral Sling Mesh Exposure
Frequency: 3 affected / 40 at risk

Adverse event: Illiac Vein Injury
Serious: no
Organ System: Surgical and medical procedures
Notes: Left Iliac Vein Injury occurred at the time of the presacral dissection
Frequency: 1 affected / 40 at risk

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

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

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Intraoperative cystotomy
Serious: no
Organ System: Surgical and medical procedures
Notes: While passing the trocar, an Intraoperative Cystotomy was encountered. This was immediately identified by Cystoscopy and removed
Frequency: 1 affected / 40 at risk
Study: NCT01125163

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The two infants (one in each group) died of Necrotizing Entercolitis which is an illness that occurs in extremely premature infants.
Frequency: 1 affected / 13 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The two infants (one in each group) died of Necrotizing Entercolitis which is an illness that occurs in extremely premature infants.
Frequency: 1 affected / 9 at risk
Study: NCT01125436

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 31 at risk