TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01512979

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Umbilical hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 159 at risk

Adverse event: Menstruation irregular
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 159 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 159 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 159 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 159 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 159 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 159 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 157 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 157 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 157 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 157 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 157 at risk
Study: NCT01513291

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 120 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 120 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 120 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 115 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 115 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk
Study: NCT01513330

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Peristomal skin redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Peristomal skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Peristomal allergic contact dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not clinically verified allergic contact dermatitis.1 subject tested 21 Nova baseplates before the AE -allergic dermatitis.1 subject tested 8 SenSura Mio baseplates during 3 days before the AE -contact dermatitis because of allergic reaction occured.
Frequency: 1 affected / 120 at risk

Adverse event: Peristomal burns
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Granulation in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Pain in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Peristomal skin redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 118 at risk

Adverse event: Peristomal skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 118 at risk

Adverse event: Peristomal allergic contact dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not clinically verified allergic contact dermatitis.1 subject tested 21 Nova baseplates before the AE -allergic dermatitis.1 subject tested 8 SenSura Mio baseplates during 3 days before the AE -contact dermatitis because of allergic reaction occured.
Frequency: 1 affected / 118 at risk

Adverse event: Localised infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Consumption of food leading to skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pain in the peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk
Study: NCT01513902

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT01514162

Adverse event: Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 245 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 245 at risk

Adverse event: Structural deterioration
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 245 at risk

Adverse event: Reoperation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 245 at risk
Study: NCT01514240

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Pneumatosis intestinalis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 56 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 56 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 56 at risk
Study: NCT01514383

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Of 74 incisions/lacerations treated in 34 patients, there was one (1) documented report of a possible incisional infection (1.4%). The complication was deemed not related to octylseal™.
Frequency: 1 affected / 34 at risk
Study: NCT01514630

Adverse event: Cold and flu symptoms
Serious: no
Organ System: General disorders
Frequency: 10 affected / 14 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

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

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

Adverse event: Swelling in Hands
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Numbness and Tingling in hands
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

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

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk
Study: NCT01514786

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Participant's death occurred during surgery totally unrelated to participation in the study. Clinic site staff member just happened to mention to research study staff this happened.
Frequency: 1 affected / 284 at risk
Study: NCT01515046

Adverse event: Anemia, grade 1
Serious: no
Organ System: Investigations
Notes: Hemoglobin, Low
Frequency: 1 affected / 1 at risk

Adverse event: white blood cell count, decreased, grade 1
Serious: no
Organ System: Investigations
Notes: leukopenia leukocytes, low
Frequency: 1 affected / 1 at risk

Adverse event: Lymphocyte count decreased, grade 2
Serious: no
Organ System: Investigations
Notes: lymphopenia
Frequency: 1 affected / 1 at risk

Adverse event: neutrophil count decreased, grade 3
Serious: no
Organ System: Investigations
Notes: neutropenia
Frequency: 1 affected / 1 at risk

Adverse event: platelet count decreased, grade 3
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Alanine aminotransferase increased, grade 1
Serious: no
Organ System: Investigations
Notes: ALT increased SGPT increased
Frequency: 1 affected / 1 at risk
Study: NCT01515072

Adverse event: DGF in kidney recipients
Serious: yes
Organ System: Renal and urinary disorders
Notes: DGF defined as dialysis within the first week after kidney transplant
Frequency: 45 affected / 247 at risk

Adverse event: Kidney rejection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney recipients that had an episode of rejection within the first 6 months
Frequency: 17 affected / 247 at risk

Adverse event: Grafts lost
Serious: yes
Organ System: General disorders
Notes: Number of grafts lost in all recipients
Frequency: 26 affected / 247 at risk

Adverse event: Recipient Deaths
Serious: yes
Organ System: General disorders
Notes: Recipient Deaths in all recipients
Frequency: 23 affected / 247 at risk

Adverse event: DGF in kidney recipients
Serious: yes
Organ System: Renal and urinary disorders
Notes: DGF defined as dialysis within the first week after kidney transplant
Frequency: 51 affected / 235 at risk

Adverse event: Kidney rejection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Kidney recipients that had an episode of rejection within the first 6 months
Frequency: 13 affected / 235 at risk

Adverse event: Grafts lost
Serious: yes
Organ System: General disorders
Notes: Number of grafts lost in all recipients
Frequency: 10 affected / 235 at risk

Adverse event: Recipient Deaths
Serious: yes
Organ System: General disorders
Notes: Recipient Deaths in all recipients
Frequency: 20 affected / 235 at risk

Adverse event: Grafts lost
Serious: yes
Organ System: General disorders
Notes: Number of grafts lost in all recipients
Frequency: 81 affected / 494 at risk

Adverse event: Recipient Deaths
Serious: yes
Organ System: General disorders
Notes: Recipient Deaths in all recipients
Frequency: 69 affected / 494 at risk

Adverse event: Grafts lost
Serious: yes
Organ System: General disorders
Notes: Number of grafts lost in all recipients
Frequency: 52 affected / 458 at risk

Adverse event: Recipient Deaths
Serious: yes
Organ System: General disorders
Notes: Recipient Deaths in all recipients
Frequency: 54 affected / 458 at risk

Adverse event: Number of Donors from which no Organs recovered
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 166 at risk

Adverse event: Number of Donors from which no Organs recovered
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 155 at risk
Study: NCT01515345

Adverse event: Definite stentthrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 664 at risk

Adverse event: probable Stentthrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 664 at risk

Adverse event: Cardiovascular death
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 664 at risk

Adverse event: Bleeding (TIMI major)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 664 at risk

Adverse event: Bleeding (TIMI minor)
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 664 at risk

Adverse event: Cardiovascular death
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 343 at risk

Adverse event: Bleeding (TIMI major)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 343 at risk

Adverse event: Bleeding (TIMI minor)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 343 at risk
Study: NCT01515410

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Parkinsonian gait
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Parkinsonian gait
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk
Study: NCT01515566

Adverse event: Pain with subcutaneous injection
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk
Study: NCT01515657

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

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

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk
Study: NCT01515696

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: intraventricular haemorrhage grade 3 and 4 according the definition of papillae et al
Frequency: 3 affected / 47 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: necrotizing enterocolitis stage II or more according to Bell
Frequency: 10 affected / 47 at risk

Adverse event: persistent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 47 at risk

Adverse event: Death
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: death because of immaturity and associated complications like multiple organ failure
Frequency: 8 affected / 47 at risk

Adverse event: culture proven sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 47 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: intraventricular haemorrhage grade 3 and 4 according the definition of papillae et al
Frequency: 3 affected / 49 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: necrotizing enterocolitis stage II or more according to Bell
Frequency: 4 affected / 49 at risk

Adverse event: persistent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 49 at risk

Adverse event: Death
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: death because of immaturity and associated complications like multiple organ failure
Frequency: 7 affected / 49 at risk

Adverse event: culture proven sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 49 at risk
Study: NCT01515865

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 71 at risk
Study: NCT01515891

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT01515995

Adverse event: Burning sensation in the nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk
Study: NCT01516008

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 114 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 114 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 114 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 114 at risk

Adverse event: Procedural site reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 121 at risk

Adverse event: Essential tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 121 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 121 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 121 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 121 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 121 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 121 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 121 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 117 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 117 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 117 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 117 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 117 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 117 at risk
Study: NCT01516034

Adverse event: Mild thickening of the skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk
Study: NCT01516268

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk
Study: NCT01516346

Adverse event: Hospital Admission
Serious: yes
Organ System: Investigations
Notes: Admission to emergency room and/or hospital
Frequency: 3 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

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

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

Adverse event: Hospital Admission
Serious: yes
Organ System: Investigations
Notes: Admission to emergency room and/or hospital
Frequency: 3 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: GI Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Orthostasis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hospital Admission
Serious: yes
Organ System: Investigations
Notes: Admission to emergency room and/or hospital
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk
Study: NCT01516437

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk