TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01049217

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 183 at risk

Adverse event: Perineal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 183 at risk

Adverse event: Demyelinating polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Peripheral sensorimotor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 183 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 183 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 183 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 183 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 183 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 183 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 183 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 192 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 192 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 192 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 192 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 192 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 192 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 192 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 192 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 192 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 192 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 192 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 192 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 192 at risk
Study: NCT01049360

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 87 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 87 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 87 at risk

Adverse event: Metastatic renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 94 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 92 at risk
Study: NCT01049802

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

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Blood pressure instability
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 20 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Floaters in visual field
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk
Study: NCT01050153

Adverse event: Decrease in Hemoglobin level more than 2g/dL in 24 hour period.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk
Study: NCT01050543

Adverse event: Post-operative abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Intestinal anastomosis complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

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

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 60 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 60 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 60 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 60 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 60 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

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

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 60 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 60 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 60 at risk
Study: NCT01050582

Adverse event: Blood prolactin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Middle insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 133 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Drug ineffective
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 51 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk
Study: NCT01050660

Adverse event: Mortality prior to discharge
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 67 at risk

Adverse event: Mortality prior to discharge
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 69 at risk
Study: NCT01050673

Adverse event: calcaneal pin site infection leading to foot gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: sacral pressure sore
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: flap dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: flap failure
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: seroma leading to limited flap dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: infection leading to prolonged hospitalisation and an amputation of the distal portion of the right
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: partial flap failure/dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk
Study: NCT01050790

Adverse event: Pain - Pack
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hospitalization. Received radiation therapy with improvement. Grade 3: Severe pain; pain or analgesics severely interfering with ADL.
Frequency: 1 affected / 17 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Hospitalization, disease progression and death occurred after 100 days. Grade 5, death.
Frequency: 1 affected / 17 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization. Grade 3, Severe pain; pain or analgesics severely interfering with ADL.
Frequency: 1 affected / 17 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3, Symptomatic, interfering with ADL; O2 indicated.
Frequency: 1 affected / 17 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization.
Frequency: 2 affected / 17 at risk

Adverse event: Mood alteration - Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Neurology, Grade 2: Mild mood alteration not interfering with function .
Frequency: 1 affected / 17 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - blood
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospitalization.
Frequency: 2 affected / 17 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization.
Frequency: 1 affected / 17 at risk

Adverse event: Mental Status
Serious: yes
Organ System: Psychiatric disorders
Notes: Neurology. Hospitalization.
Frequency: 1 affected / 17 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization. Grade 3: Requiring more than one drug or more intensive therapy than previously.
Frequency: 1 affected / 17 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2-3.
Frequency: 2 affected / 17 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2-3.
Frequency: 11 affected / 17 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2-3.
Frequency: 2 affected / 17 at risk

Adverse event: High Creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2-3.
Frequency: 1 affected / 17 at risk

Adverse event: High AST
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2-3.
Frequency: 1 affected / 17 at risk

Adverse event: High ALT
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2-3.
Frequency: 1 affected / 17 at risk
Study: NCT01050907

Adverse event: Epididymitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT01050946

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient underwent an EGD on 5/5/11 to evaluate for GI motility problems and gastric outlet obstruction. During the procedure patient became hypoxic and required intubation. Patient developed Acute Respiratory Distress Syndrome (ARDS).
Frequency: 1 affected / 1 at risk

Adverse event: Acute Renal Injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute Renal Injury with previous history of tubular necrosis on 3/29/11.
Frequency: 1 affected / 1 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Patient was admitted to hospital for management of altered mental status for acute onset of confusion.
Frequency: 1 affected / 1 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Due to worsening CMV and BK virus/ Hemorrhagic Cystitis patient decided to receive only palliative care. Patient was receiving palliative care at the time of her death.
Frequency: 1 affected / 1 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient underwent an EGD on 5/5/11 to evaluate for GI motility problems and gastric outlet obstruction. During the procedure patient became hypoxic and required intubation. Patient developed Acute Respiratory Distress Syndrome (ARDS).
Frequency: 1 affected / 1 at risk

Adverse event: Acute Renal Injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Acute Renal Injury with previous history of tubular necrosis on 3/29/11.
Frequency: 1 affected / 1 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Patient was admitted to hospital for management of altered mental status for acute onset of confusion.
Frequency: 1 affected / 1 at risk

Adverse event: Death
Serious: no
Organ System: Infections and infestations
Notes: Due to worsening CMV and BK virus/ Hemorrhagic Cystitis patient decided to receive only palliative care. Patient was receiving palliative care at the time of her death.
Frequency: 1 affected / 1 at risk
Study: NCT01051310

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 18 at risk

Adverse event: Documented Mobitz type II AVB II, AVB III
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 18 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Notes: Any other reported adverse event not associated with the use of the study device were collected without a specific adverse event term
Frequency: 12 affected / 18 at risk

Adverse event: bleeding event
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 18 at risk

Adverse event: Neurological events (CVA, RIND, TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: non structural valve dysfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 18 at risk

Adverse event: Surgical aortic valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 18 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Notes: Any other reported adverse event not associated with the use of the study device were collected without a specific adverse event term
Frequency: 13 affected / 18 at risk

Adverse event: bleeding event
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 18 at risk
Study: NCT01051817

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 35 at risk

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

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 38 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 38 at risk
Study: NCT01051856

Adverse event: Hospital readmission for pancreatic fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Percutaneous Drainage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 32 at risk

Adverse event: Intensive Care Unit or Progressive Care Unit Stay
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pancreatic fistula drainage longer than 3 weeks
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 32 at risk

Adverse event: Drained Amylase 3 Times Normal Upper Limit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 32 at risk

Adverse event: Specific Treatment for Pancreatic Fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Pancreatic Fistula Documented by X-Ray
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: Post procedural infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 32 at risk

Adverse event: Hospital readmission for pancreatic fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Percutaneous Drainage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 35 at risk

Adverse event: Pseudoaneurysm due to pancreatic fistula
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Intensive Care Unit or Progressive Care Unit Stay
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pancreatic fistula drainage longer than 3 weeks
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Drained Amylase 3 Times Normal Upper Limit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 35 at risk

Adverse event: Specific Treatment for Pancreatic Fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 35 at risk

Adverse event: Pancreatic Fistula Documented by X-Ray
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Post procedural infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 35 at risk
Study: NCT01051960

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 12 at risk

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

Adverse event: Joint and body pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Elevated liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Body tinea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bronchoalveolar carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 12 at risk

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

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk