TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01976507

Adverse event: Pericardial Effusion with Tamponade
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Upper Gi Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Migraine with aura
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pericardial Pain/Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Carotid Stenosis/Carotid Endarterectomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 100 at risk
Study: NCT01976624

Adverse event: Neoplasm metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Investigator determined not-related to study medication.
Frequency: 1 affected / 742 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 86 affected / 742 at risk
Study: NCT01976650

Adverse event: Ocular Tension Decreased
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 718 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 718 at risk

Adverse event: Macula Lutea
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 718 at risk
Study: NCT01976806

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Intermittent palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Gingival bleeding while flossing
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

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

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

Adverse event: Dental caries
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Verbally abusive toward staff
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk
Study: NCT01976819

Adverse event: stoma irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: stoma irritation occurred when twisting device
Frequency: 1 affected / 16 at risk

Adverse event: sound leakage past cannula
Serious: no
Organ System: Surgical and medical procedures
Notes: sound leakage past cannula when coughing
Frequency: 1 affected / 16 at risk
Study: NCT01976871

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 20 at risk

Adverse event: Worsening of RLS symptoms during cross-titration
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Skin reaction at patch application site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 20 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk
Study: NCT01977092

Adverse event: Depressive symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 149 at risk

Adverse event: Suicidal symptoms
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalizations due to suicidal symptoms
Frequency: 3 affected / 149 at risk

Adverse event: Staph infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 149 at risk

Adverse event: Unconsciousness NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 149 at risk

Adverse event: Acute embolism and thrombosis of unspecified deep veins of lower extremity
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: ppt reported hospitalization due to a blood clot in leg
Frequency: 1 affected / 149 at risk

Adverse event: Infarction of spleen
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 149 at risk

Adverse event: Biliary acute pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 149 at risk

Adverse event: Contusions
Serious: yes
Organ System: General disorders
Notes: Ppt was assaulted and hospitalized overnight due to injuries.
Frequency: 1 affected / 149 at risk

Adverse event: Depressive symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 181 at risk

Adverse event: Suicidal symptoms
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalizations due to suicidal symptoms
Frequency: 15 affected / 181 at risk

Adverse event: Contusions and lacerations
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 181 at risk

Adverse event: Cardiac arrhythmia, unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 181 at risk

Adverse event: Alcohol withdrawal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Unspecified asthma with (acute) exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 181 at risk

Adverse event: Fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 181 at risk

Adverse event: Seizure disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 181 at risk

Adverse event: Unconsciousness NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Gastrointestinal hemorrhage, unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ppt reported they had internal bleeding due to drug use
Frequency: 1 affected / 181 at risk
Study: NCT01977352

Adverse event: ED visit
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT01977417

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT01977547

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 728 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 728 at risk

Adverse event: Hypocalemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 728 at risk

Adverse event: Major Allergic Reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 728 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 728 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 733 at risk

Adverse event: Haemolytic transfusion reaction
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 733 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 733 at risk

Adverse event: Hypocalemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 733 at risk

Adverse event: Major Allergic Reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 733 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 733 at risk

Adverse event: Transfusion Associated Cardiac Overload
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 733 at risk
Study: NCT01977625

Adverse event: Increase heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increase blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk
Study: NCT01977781

Adverse event: Ocular Burning Sensation
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 24 at risk

Adverse event: Ocular Discharge
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 24 at risk

Adverse event: Ocular Redness
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 24 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 24 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 24 at risk

Adverse event: Ocular Burning Sensation
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 16 at risk

Adverse event: Ocular Discharge
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 16 at risk

Adverse event: Ocular Redness
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 16 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 16 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 16 at risk
Study: NCT01977794

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 100 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 100 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 100 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 100 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 100 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 100 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 100 at risk
Study: NCT01977820

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

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

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

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01977937

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk
Study: NCT01978119

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 82 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 82 at risk
Study: NCT01978145

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 426 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 426 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 426 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 426 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 426 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 426 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 426 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 426 at risk

Adverse event: Pickwickian syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 426 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 426 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 426 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 426 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 426 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 426 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 426 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 426 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 426 at risk

Adverse event: Rectosigmoid cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 426 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 426 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 426 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 426 at risk
Study: NCT01978262

Adverse event: Chills
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 92 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 92 at risk

Adverse event: Eythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Immune system disorders
Frequency: 23 affected / 92 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 92 at risk

Adverse event: Malaise
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 92 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 92 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 92 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 92 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 92 at risk
Study: NCT01978938

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 455 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 455 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 455 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 455 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 455 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 455 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 455 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 450 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 450 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 450 at risk

Adverse event: Psoas abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 450 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 450 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 450 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 450 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 450 at risk
Study: NCT01979029

Adverse event: anastomotic leakage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 29 at risk

Adverse event: anastomotic leakage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 28 at risk
Study: NCT01979185

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk
Study: NCT01979835

Adverse event: Perforation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 1012 at risk

Adverse event: expulsion
Serious: no
Organ System: Reproductive system and breast disorders
Notes: IUD expulsion
Frequency: 36 affected / 1012 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 11 affected / 1012 at risk

Adverse event: too much bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 92 affected / 1012 at risk

Adverse event: too much pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 27 affected / 1012 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 1012 at risk
Study: NCT01980095

Adverse event: Anemia of Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 77 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 77 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 77 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk