TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01471015

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Defined as systolic blood pressure \</= to 50 mmHg requiring inotrope support
Frequency: 4 affected / 10 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 10 at risk

Adverse event: Altered Hepatic Function
Serious: no
Organ System: Hepatobiliary disorders
Notes: Defined as aspartate aminotransferase (AST) \>200 IU/L or alanine aminotransferase (ALT) \>100 IU/L
Frequency: 2 affected / 10 at risk

Adverse event: Altered Renal Function
Serious: no
Organ System: Renal and urinary disorders
Notes: Defined as urine output \<0.5 mL/k/h for \>24 hours or serum creatinine \>1.5 mg/dL
Frequency: 3 affected / 10 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: New onset seizures that appeared after the first dose of study drug
Frequency: 3 affected / 10 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Multi-organ failure due to Hypoxic-Ischemic Encephalopothy
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Defined as systolic blood pressure \</= to 50 mmHg requiring inotrope support
Frequency: 4 affected / 10 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 10 at risk

Adverse event: Altered Hepatic Function
Serious: no
Organ System: Hepatobiliary disorders
Notes: Defined as aspartate aminotransferase (AST) \>200 IU/L or alanine aminotransferase (ALT) \>100 IU/L
Frequency: 1 affected / 10 at risk

Adverse event: Altered Renal Function
Serious: no
Organ System: Renal and urinary disorders
Notes: Defined as urine output \<0.5 mL/k/h for \>24 hours or serum creatinine \>1.5 mg/dL
Frequency: 6 affected / 10 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: New onset seizures that appeared after the first dose of study drug
Frequency: 2 affected / 10 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Multi-organ failure due to Hypoxic-Ischemic Encephalopothy
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Defined as systolic blood pressure \</= to 50 mmHg requiring inotrope support
Frequency: 4 affected / 10 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Altered Hepatic Function
Serious: no
Organ System: Hepatobiliary disorders
Notes: Defined as aspartate aminotransferase (AST) \>200 IU/L or alanine aminotransferase (ALT) \>100 IU/L
Frequency: 1 affected / 10 at risk

Adverse event: Altered Renal Function
Serious: no
Organ System: Renal and urinary disorders
Notes: Defined as urine output \<0.5 mL/k/h for \>24 hours or serum creatinine \>1.5 mg/dL
Frequency: 3 affected / 10 at risk
Study: NCT01471041

Adverse event: Stenosis at VWING
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Cannulation pain resulting in VWING removal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Inability to cannulate resulting in VWING removal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Infiltration
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 54 at risk

Adverse event: Unable to cannulate
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 54 at risk

Adverse event: Stenosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 54 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 54 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Seroma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Possible dislodge VWING
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Bleeding following cannulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Incision dehiscence
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk
Study: NCT01471093

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

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

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk
Study: NCT01471171

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 111 at risk

Adverse event: Troponin T increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 108 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Preferred term was coded as chronic obstructive pulmonary disease (COPD). However, per protocol, only COPD exacerbations (worsening of COPD symptoms for at least 2 consecutive days that required a change in COPD treatment) were reported as AEs.
Frequency: 1 affected / 108 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 108 at risk
Study: NCT01471379

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk
Study: NCT01471457

Adverse event: Any vaginal symptom attributable possibly to pessary
Serious: no
Organ System: Reproductive system and breast disorders
Notes: At least one or more vaginal symtoms (itching, pain, discharge, etc) that has increased since pessary fitting at 9 mo
Frequency: 18 affected / 92 at risk

Adverse event: Any vaginal symptom attributable possibly to pessary
Serious: no
Organ System: Reproductive system and breast disorders
Notes: At least one or more vaginal symtoms (itching, pain, discharge, etc) that has increased since pessary fitting at 9 mo
Frequency: 13 affected / 92 at risk
Study: NCT01471522

Adverse event: Cardiovascular Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 92 affected / 2588 at risk

Adverse event: Procedural Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 2588 at risk

Adverse event: Non-procedural Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 130 affected / 2588 at risk

Adverse event: Hospitalization for Unstable Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 2588 at risk

Adverse event: Hospitalization for Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 51 affected / 2588 at risk

Adverse event: Resuscitated Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2588 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 45 affected / 2588 at risk

Adverse event: Cardiovascular Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 111 affected / 2591 at risk

Adverse event: Procedural Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 2591 at risk

Adverse event: Non-procedural Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 196 affected / 2591 at risk

Adverse event: Hospitalization for Unstable Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 2591 at risk

Adverse event: Hospitalization for Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 2591 at risk

Adverse event: Resuscitated Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2591 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 2591 at risk
Study: NCT01471639

Adverse event: Discomfort (burning feeling of nasal mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 7 individual felt discomfort (a burning feeling) of the nasal mucosa. This resolved quickly, within minutes. Inspection of the nasal mucosa showed no visible abnormalities.
Frequency: 7 affected / 37 at risk
Study: NCT01471691

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Patient developed breast cancer during trial. It was treated by her oncologist. Not felt to be secondary to Ranibizumab.
Frequency: 1 affected / 8 at risk

Adverse event: Ruptured Retinal Macroaneurysm
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 8 at risk
Study: NCT01472185

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Sinoatrial block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 232 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 232 at risk

Adverse event: Non-small cell lung cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 232 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 232 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 232 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 232 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 232 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 232 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 232 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 232 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 232 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 232 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 232 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 232 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 232 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 232 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 232 at risk
Study: NCT01472289

Adverse event: Major Limb Amputation
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 17 at risk

Adverse event: Minor Limb Amputation
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 17 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 17 at risk
Study: NCT01472341

Adverse event: Death due to parotid cancer in advanced stage [Salivary gland cancer]
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 507 at risk
Study: NCT01472380

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 28 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 28 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 28 at risk
Study: NCT01472445

Adverse event: Primary hyperparathyroidism (HPT)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Neuroendocrine cancer of the breast, metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 16 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Plasma chromogranin A level, elevated
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk
Study: NCT01472549

Adverse event: Adverse skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse skin reactions including erythema, skin irritation and allergic skin reactions.
Frequency: 15 affected / 572 at risk

Adverse event: Adverse skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse skin reactions including erythema, skin irritation and allergic skin reactions.
Frequency: 15 affected / 575 at risk
Study: NCT01472835

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

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Less than 1 day
Frequency: 1 affected / 37 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Less than 1 day
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Less than 1 day
Frequency: 1 affected / 36 at risk

Adverse event: Worse pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Less than 1 week
Frequency: 2 affected / 36 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Notes: Less than 1 day
Frequency: 1 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Less than 1 day
Frequency: 1 affected / 36 at risk
Study: NCT01472939

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 122 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 122 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 122 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 119 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 119 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 119 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 118 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 118 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 118 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 118 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 118 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 118 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 118 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 118 at risk
Study: NCT01472965

Adverse event: Line fracture or split
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 48 at risk

Adverse event: Chest pain (infusional)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Line fracture or split
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 46 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk
Study: NCT01473355

Adverse event: Fracture left leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Possible ablepsia of right eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk
Study: NCT01473368

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastrointestinal motility disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Vulvovaginal rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk