TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02013765

Adverse event: Pain - stomach
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Obstruction - GU
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain - extremity, limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain - headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Constitutional symptoms - other (not specified)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Infection - other (not specified)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Infection with unknown absolute neutrophil count (ANC)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Metabolic/laboratory - other (not specified)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk
Study: NCT02013778

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk
Study: NCT02014272

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 27 at risk

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

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

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 27 at risk
Study: NCT02014480

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 202 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 200 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 202 at risk
Study: NCT02014584

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 59 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 58 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 58 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 49 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 48 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 48 at risk
Study: NCT02014649

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tonsillitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Otitis media bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

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

Adverse event: Tympanic membrane disorder
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02014740

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 45 at risk
Study: NCT02015195

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: erythema
Frequency: 1 affected / 1 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT02015221

Adverse event: Ulcer / Blister
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 41 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk
Study: NCT02015234

Adverse event: Pubic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 79 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 79 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 79 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 79 at risk

Adverse event: Product taste abnormal
Serious: no
Organ System: General disorders
Frequency: 9 affected / 79 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 79 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

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

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 79 at risk

Adverse event: Brain stem glioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 79 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 79 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 79 at risk
Study: NCT02015390

Adverse event: 6 months post reconstructive surgery
Serious: yes
Organ System: Infections and infestations
Notes: A 48-old male patients randomized to the Cage Arm for the treatment of his 5-cm-long midshaft tibial bone defect, presented to the clinic at 6-months post reconstructive surgery with infected draining wound and defect infection.
Frequency: 1 affected / 7 at risk

Adverse event: 3 weeks post reconstructive surgery
Serious: yes
Organ System: Infections and infestations
Notes: A 36-year-old female with a infected tibia nonunion treated with the Cage Technique and allograft developed wound dehiscence and defects infection which resulted from noncompliance with antibiotic therapy and intravenous illicit drug abuse.
Frequency: 1 affected / 7 at risk

Adverse event: 18 months post reconstructive surgery
Serious: yes
Organ System: Infections and infestations
Notes: A 47-year-old female who received the Cage reconstruction for a 6.5-cm midshaft humerus defect presented with infection 3 days before the final 18-month follow-up. Patient was reported as noncompliant with positive illegal drug amphetamine in blood.
Frequency: 1 affected / 7 at risk
Study: NCT02015455

Adverse event: Emergency Department visit within 90 days of index imaging
Serious: yes
Organ System: General disorders
Notes: Emergency Department visits were identified in the health systems' medical records.
Frequency: 12885 affected / 117455 at risk

Adverse event: Emergency Department visit within 90 days of index imaging
Serious: yes
Organ System: General disorders
Notes: Emergency Department visits were identified in the health systems' medical records.
Frequency: 13289 affected / 121431 at risk
Study: NCT02015546

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

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 14 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 19 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 22 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 22 affected / 22 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 22 at risk
Study: NCT02015637

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 304 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 154 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 154 at risk
Study: NCT02015832

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 454 at risk

Adverse event: All-cause Revascularization
Serious: yes
Organ System: Cardiac disorders
Frequency: 60 affected / 454 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 454 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 454 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 454 at risk
Study: NCT02016170

Adverse event: Angioedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 27 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 28 at risk
Study: NCT02016612

Adverse event: skin dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin dehiscence
Frequency: 2 affected / 25 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Superficial infection limited to the skin
Frequency: 1 affected / 25 at risk

Adverse event: skin dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin dehiscence
Frequency: 1 affected / 25 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Superficial infection limited to the skin
Frequency: 1 affected / 25 at risk

Adverse event: Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: seroma and partial Seri removal
Frequency: 3 affected / 26 at risk

Adverse event: Dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: skin dehiscence
Frequency: 3 affected / 26 at risk

Adverse event: skin dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin dehiscence
Frequency: 3 affected / 26 at risk

Adverse event: Seroma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: seroma and partial Seri removal
Frequency: 2 affected / 61 at risk

Adverse event: Dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: skin dehiscence
Frequency: 2 affected / 61 at risk

Adverse event: skin dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin dehiscence
Frequency: 2 affected / 61 at risk
Study: NCT02016898

Adverse event: Cystic blebs
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 50 at risk

Adverse event: Shallowing of anterior chamber
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypotony
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 50 at risk

Adverse event: Choroidal effusion
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 50 at risk

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

Adverse event: Wound leak
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 50 at risk

Adverse event: Cystic blebs
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 45 at risk

Adverse event: Shallowing of anterior chamber
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk

Adverse event: Hypotony
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 45 at risk

Adverse event: Choroidal effusion
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk

Adverse event: Suprachoroidal hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hyphaema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Wound leak
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 45 at risk
Study: NCT02016963

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

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

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

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

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

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT02017327

Adverse event: intervetebral disk protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 130 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 130 at risk
Study: NCT02017964

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Other, Progression Of Medulloblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 25 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 25 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 25 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 25 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 25 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk
Study: NCT02018042

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper Respiratory illnesses including common cold-like symptoms, flu, pneumonia, or otherwise associated symptoms.
Frequency: 6 affected / 15 at risk

Adverse event: Site Injection
Serious: no
Organ System: Product Issues
Notes: Site injection of the medication into the body included body aches, tightness at the injection site, and tingling of the hands/arms which resolved during the study period.
Frequency: 3 affected / 15 at risk

Adverse event: Candidiasis/Yeast Infection
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Infection of the genitourinary tract which resolved with miconazole prior to the treatment end.
Frequency: 1 affected / 15 at risk
Study: NCT02018315

Adverse event: Gastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk