TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01623466

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 18 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Reproductive system ad breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 18 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 18 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 18 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 18 at risk

Adverse event: Reproductive system ad breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 18 at risk
Study: NCT01623479

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 585 at risk

Adverse event: Erythema of the Eyelid
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 585 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 36 affected / 585 at risk

Adverse event: Ocular Irritation
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 585 at risk
Study: NCT01623531

Adverse event: Re-Operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Re-exploration with Re-sternotomy because of acute cardiac tamponade or diffuse or surgical bleeding
Frequency: 1 affected / 27 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Upper extremity weakness
Frequency: 1 affected / 27 at risk

Adverse event: Postoperative delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Notes: Generalized, diffuse brain edema on postop. day 1 after hemi aortic arch repair
Frequency: 1 affected / 27 at risk

Adverse event: Incisional wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Re-Operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Re-exploration with Re-sternotomy because of acute cardiac tamponade or diffuse or surgical bleeding
Frequency: 4 affected / 29 at risk

Adverse event: Postoperative delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 29 at risk

Adverse event: Incisional wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk
Study: NCT01623739

Adverse event: Swelling and bruising
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 15 at risk
Study: NCT01624194

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Excitement/Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Labile Mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Silly Behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: More Distractible
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

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

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

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

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Excitement/Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 18 at risk

Adverse event: Depressive Affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Labile Mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Sneezing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blinking Eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Skin Cut
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk
Study: NCT01624506

Adverse event: Device erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 530 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 530 at risk

Adverse event: Gatric pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 530 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 530 at risk

Adverse event: Worsening of GERD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 530 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 530 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 530 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Worsening of GERD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 230 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 230 at risk
Study: NCT01624740

Adverse event: Administration Site Condition (Device Stimulation Issues)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Administration Site Condition (Device Stimulation Issues)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT01624870

Adverse event: Permanent Pacemaker Implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 50 affected / 194 at risk

Adverse event: Stroke-TIA
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 194 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 55 affected / 194 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 194 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 194 at risk

Adverse event: Coronary obstruction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 194 at risk

Adverse event: Vascular access site and access-related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 44 affected / 194 at risk

Adverse event: Valve-related dysfunction requiring repeat procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 194 at risk

Adverse event: Stroke-TIA
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 194 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 194 at risk

Adverse event: Bleeding Event
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 194 at risk

Adverse event: Permanent Pacemaker Implantation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 194 at risk

Adverse event: Re-intervention
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 194 at risk

Adverse event: Vascular access site and access-related complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 194 at risk

Adverse event: Other Adverse Event
Serious: no
Organ System: General disorders
Notes: Any other reported adverse event not associated with the use of the study device were collected without a specific adverse event term.
Frequency: 136 affected / 194 at risk
Study: NCT01624974

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 96 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 96 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 97 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 97 at risk
Study: NCT01625013

Adverse event: Severe Swelling, Pain, and/or Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 51 at risk

Adverse event: Reinjury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 knee reinjury while playing sports; 1 reinjury while twisting knee, leading to meniscus tear
Frequency: 2 affected / 51 at risk
Study: NCT01625091

Adverse event: Inpatient hospitalization
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 96 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 96 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 96 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 96 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 21 affected / 96 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 96 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 24 affected / 96 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 23 affected / 96 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 96 at risk

Adverse event: Nervousness/Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 96 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 96 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 96 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 96 at risk

Adverse event: Inpatient hospitalization
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 98 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 98 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 23 affected / 98 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 19 affected / 98 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 98 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 98 at risk

Adverse event: Nervousness/Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 98 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 98 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 98 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 98 at risk
Study: NCT01625169

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: One patient out of 9 (11%) reported diarrhea at the D5 PK visit.
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1 of 9 (11%) reported a self-resolving headache on D14; not likely to be related to ETR.
Frequency: 1 affected / 9 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 66% of the subjects complained of breast tenderness related to pumping.
Frequency: 6 affected / 9 at risk
Study: NCT01625221

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 35 at risk

Adverse event: Device erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Impaction or defecatory disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Allergy, inflammation reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Device erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 35 at risk

Adverse event: Impaction or defecatory disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk
Study: NCT01625416

Adverse event: Suicide ideation
Serious: no
Organ System: Psychiatric disorders
Notes: PHQ-9 Score of \>0
Frequency: 31 affected / 60 at risk

Adverse event: Suicide ideation
Serious: no
Organ System: Psychiatric disorders
Notes: PHQ-9 Score of \>0
Frequency: 36 affected / 61 at risk
Study: NCT01625689

Adverse event: Traumatic Injury/fracture/overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 150 at risk

Adverse event: abdominal pain/gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: diarrheal illness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 150 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 150 at risk

Adverse event: Boil/Abscess/skin infection/ulcer/cyst
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 150 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 150 at risk

Adverse event: Scabies
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 150 at risk

Adverse event: Abdominal pain/distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 150 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 150 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 150 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 150 at risk

Adverse event: diarrheal illness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 150 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 150 at risk

Adverse event: Boil/Abscess/skin infection/ulcer/cyst
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 150 at risk

Adverse event: Helminthiasis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 150 at risk

Adverse event: Scabies
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 150 at risk

Adverse event: Abdominal pain/distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 150 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 150 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 150 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 150 at risk
Study: NCT01625923

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk
Study: NCT01625988

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 107 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 107 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 107 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 107 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 110 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 110 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 110 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 110 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 110 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 80 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 98 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 98 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk