TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02400671

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 276 at risk

Adverse event: Infant death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 276 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 276 at risk

Adverse event: Infant hospitalization
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 276 at risk

Adverse event: Miscarriage/stillbirth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 276 at risk

Adverse event: Psychological distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 276 at risk

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 271 at risk

Adverse event: Infant death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 271 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infant hospitalization
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 271 at risk

Adverse event: Miscarriage/stillbirth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 271 at risk

Adverse event: Physical or sexual abuse
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 271 at risk

Adverse event: Maternal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 277 at risk

Adverse event: Infant death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 277 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 277 at risk

Adverse event: Infant hospitalization
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 277 at risk

Adverse event: Miscarriage/stillbirth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 277 at risk
Study: NCT02400723

Adverse event: Abdominal pain, muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Strained muscle in abdomen, stomach discomfort.
Frequency: 1 affected / 27 at risk
Study: NCT02400749

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: E. coli bacteremia, C-difficile + hypokalemia requiring hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Carbon monoxide poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 50 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 50 at risk

Adverse event: breast cancer requiring hospitalization for bilateral mastectomy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 50 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 50 at risk
Study: NCT02400996

Adverse event: Pancreatic fistula
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A pancreatic fistula was defined as drainage of more than 30 mL of fluid per day with amylase levels at least 3 times the normal serum amylase levels from the sixth postoperative day
Frequency: 6 affected / 40 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Notes: Delayed gastric emptying was defined as intolerance to oral feeds requiring nasogastric aspiration after the sixth postoperative day.
Frequency: 8 affected / 40 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Wound Infection was defined as purulent discharge from the main wound with positive culture report.
Frequency: 4 affected / 40 at risk

Adverse event: Intraabdominal Abscess
Serious: no
Organ System: Infections and infestations
Notes: Intraabdominal Abscess was defined as purulent fluid of any amount inside the abdomen requiring percutaneous drainage or laparotomy.
Frequency: 2 affected / 40 at risk

Adverse event: Post procedural fever
Serious: no
Organ System: General disorders
Notes: Postoperative fever was defined as core body temperature more than 100 F sustained enough to require medication and search for its cause after surgery.
Frequency: 2 affected / 40 at risk
Study: NCT02401035

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Catheter site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Catheter site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Vessel puncture site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Epiphyses delayed fusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Adenoidal hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT02401230

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk
Study: NCT02401256

Adverse event: Efavirenz side effects
Serious: no
Organ System: General disorders
Notes: Most common efavirenz side effects observed in this study: dizziness, nausea, vivid dreams, lack of concentration, headache, itching and rash (data collected using questionnaire and patient interview)
Frequency: 5 affected / 70 at risk
Study: NCT02401412

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Death due to septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Intestinal Blockage/Illeus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Acute shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Death due to primary cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Elective colonoscopy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 79 at risk

Adverse event: Incisional Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Intestinal Blockage/Illeus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Stoma abrasion caused by patient
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 79 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Ostomy pouching system not secure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 79 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Intestinal Blockage/Illeus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Inflamed gall bladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Non-specific Failure to Thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Non-specific Pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Intestinal Blockage/Illeus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Peristomal Skin Complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 74 at risk

Adverse event: Stoma complication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 74 at risk
Study: NCT02401464

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 26 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk
Study: NCT02401672

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache, discomfort , unpleasant or scalp pain.
Frequency: 14 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache, discomfort , unpleasant or scalp pain.
Frequency: 8 affected / 17 at risk
Study: NCT02402153

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: Not device related
Frequency: 1 affected / 18 at risk

Adverse event: Includes either ear swelling, ear discomfort, ear pain, or ear deformity acquired
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Device related
Frequency: 7 affected / 18 at risk

Adverse event: Vomiting and diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not device related
Frequency: 1 affected / 18 at risk

Adverse event: Includes either implant site haematoma, discomfort or implant site pain
Serious: no
Organ System: General disorders
Notes: Device related
Frequency: 3 affected / 18 at risk

Adverse event: Includes either nasopharyngitis, ear infection or food poisoning
Serious: no
Organ System: Infections and infestations
Notes: Not device related
Frequency: 6 affected / 18 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not device related
Frequency: 1 affected / 18 at risk

Adverse event: Includes either headache, post procedural headache or migrane
Serious: no
Organ System: Nervous system disorders
Notes: Device related
Frequency: 4 affected / 18 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Not device related
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Not device related
Frequency: 1 affected / 18 at risk
Study: NCT02402309

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urine abnormality
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk
Study: NCT02402452

Adverse event: Vessel puncture site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02402933

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 22 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Incorrect dose administered
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypoglycemia Questionnaire vocabulary name.
Frequency: 19 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

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

Adverse event: Product taste abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Watery Eyes
Serious: no
Organ System: Eye disorders
Notes: Hypoglycemia Questionnaire vocabulary name.
Frequency: 18 affected / 22 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk
Study: NCT02403479

Adverse event: Acute exacerbation of sinusitis/severe nasal obstruction
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk
Study: NCT02403830

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 29 at risk

Adverse event: nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypertensive urgency
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk