TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03161678

Adverse event: Knee Pain/Swelling
Serious: no
Organ System: General disorders
Notes: Knee pain and swelling began after participant started taking clopidogrel 75 mg daily.
Frequency: 1 affected / 19 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Notes: Dyspnea occurred in 1 individual a few days after starting the ticagrelor intervention
Frequency: 1 affected / 21 at risk
Study: NCT03161938

Adverse event: bleeding, intraoperative
Serious: yes
Organ System: Surgical and medical procedures
Notes: intraoperative bleeding, arterial damage
Frequency: 1 affected / 32 at risk
Study: NCT03162458

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Administration related reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Otosalpingitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 71 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 71 at risk

Adverse event: Right otitis media (acute, non-suppurative)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 71 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 71 at risk
Study: NCT03162783

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Notes: Transient and self-limiting instillation site irritation that resolved in all cases.
Frequency: 17 affected / 17 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Notes: Transient and self-limiting instillation site irritation that resolved in all cases.
Frequency: 8 affected / 17 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Notes: Transient and self-limiting instillation site irritation that resolved in all cases.
Frequency: 16 affected / 17 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Eyelid margin crusting
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk
Study: NCT03163758

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

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk
Study: NCT03163992

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 60 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: elevated liver enzyme
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 60 at risk

Adverse event: hyperbilirubinemina
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 60 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 60 at risk
Study: NCT03164668

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

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

Adverse event: Lightheaded
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk
Study: NCT03165045

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1322 at risk
Study: NCT03165110

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk
Study: NCT03165916

Adverse event: Biliary Complications
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 58 at risk

Adverse event: Biliary Complications
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 57 at risk
Study: NCT03165981

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Subject presented with fever, upper respiratory symptoms, decreased oral intake and dehydration 13 days after Visit 1. The SAE was considered unrelated to vaccination by the investigator.
Frequency: 1 affected / 107 at risk
Study: NCT03166124

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk

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

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

Adverse event: Nasopharyngitis
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: 4 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk
Study: NCT03167099

Adverse event: Failure of Fixation
Serious: yes
Organ System: Product Issues
Notes: X-ray shows failure of fixation of right distal femur fracture. Removal of hardware with right distal femoral replacement performance
Frequency: 1 affected / 26 at risk

Adverse event: Fracture from fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fell day after discharge following initial femur repair, fracturing other side. ORIF (open reduction and internal fixation) to other femur performed.
Frequency: 1 affected / 26 at risk

Adverse event: Nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Evidence of left distal femoral nonunion. Revision performed 11 months postoperatively.
Frequency: 1 affected / 27 at risk

Adverse event: Fall unknown source
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Left periprosthetic proximal femur fracture, open exam under anesthesia performed.
Frequency: 1 affected / 27 at risk

Adverse event: COPD (Chronic Obstructive Pulmonary Disease)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Visit to Emergency Department, complaints of shortness of breath and back pain. Chest x-ray, EKG, and lab work were completed. Clinically stable and discharged home same day. Instructed to follow-up with primary care provider.
Frequency: 1 affected / 27 at risk
Study: NCT03167151

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash over bilateral shins
Frequency: 1 affected / 2 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk
Study: NCT03167359

Adverse event: Recurrance
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 74 at risk
Study: NCT03167411

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk
Study: NCT03167541

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT03168022

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 42 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 42 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: General disorders
Frequency: 4 affected / 42 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 43 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: General disorders
Frequency: 5 affected / 43 at risk
Study: NCT03168308

Adverse event: Reintubation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 48 at risk

Adverse event: Critical respiratory or circulatory events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Symptoms of residual neuromuscular blockade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 48 at risk
Study: NCT03168321

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 392 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 392 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 392 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 399 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 399 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 399 at risk
Study: NCT03168334

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 387 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 387 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 387 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 392 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 392 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 392 at risk
Study: NCT03168425

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 94 at risk
Study: NCT03168555

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: SNOMED CT: 25064002
Frequency: 1 affected / 22 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: SNOMED CT: 37796009
Frequency: 1 affected / 22 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Notes: SNOMED CT: 404640003
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: SNOMED CT:224960004
Frequency: 2 affected / 22 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 116289008
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 422587007
Frequency: 3 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT:62315008
Frequency: 14 affected / 22 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 271834000
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 21522001
Frequency: 3 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT:16331000
Frequency: 1 affected / 22 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: SNOMED CT:367391008
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal sounds/growling
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 249503000
Frequency: 5 affected / 22 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 116289008
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 422587007
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT:62315008
Frequency: 14 affected / 18 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 21522001
Frequency: 5 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT:16331000
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal sounds/growling
Serious: no
Organ System: Gastrointestinal disorders
Notes: SNOMED CT: 249503000
Frequency: 2 affected / 18 at risk
Study: NCT03168841

Adverse event: Application site vesicles, local
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 40 at risk
Study: NCT03168867

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 14 affected / 74 at risk

Adverse event: New Non-diabetes-Related Health Problem
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 74 at risk

Adverse event: Blood glucose less than 50 mg/dL
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 74 at risk

Adverse event: Worsening Diabetes-Related Health Problem
Serious: yes
Organ System: Endocrine disorders
Frequency: 10 affected / 74 at risk

Adverse event: Aggression
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 74 at risk

Adverse event: New Diabetes-Related Health Problem
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 74 at risk

Adverse event: New Non-diabetes-Related Health Problem
Serious: no
Organ System: Surgical and medical procedures
Frequency: 16 affected / 74 at risk

Adverse event: Problem with Parent-Child Relations
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 74 at risk

Adverse event: Psychiatric Problem
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 74 at risk

Adverse event: School Related Problem
Serious: no
Organ System: Social circumstances
Frequency: 4 affected / 74 at risk

Adverse event: Worsening Diabetes-Related Health Problem
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 74 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 11 affected / 75 at risk

Adverse event: New Non-diabetes-Related Health Problem
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 75 at risk

Adverse event: Blood glucose less than 50 mg/dL
Serious: yes
Organ System: Endocrine disorders
Frequency: 10 affected / 75 at risk

Adverse event: Worsening Diabetes-Related Health Problem
Serious: yes
Organ System: Endocrine disorders
Frequency: 6 affected / 75 at risk

Adverse event: New Psychiatric Problem
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 75 at risk

Adverse event: New Diabetes-Related Health Problem
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 75 at risk

Adverse event: New Non-diabetes-Related Health Problem
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 75 at risk

Adverse event: Problem with Parent-Child Relations
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 75 at risk

Adverse event: Psychiatric Problem
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 75 at risk

Adverse event: School Related Problem
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 75 at risk

Adverse event: Worsening Diabetes-Related Health Problem
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 75 at risk

Adverse event: New Family Problem
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 75 at risk
Study: NCT03168906

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

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Upper and lower extremity swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

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

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