TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03328182

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Patient passed due to sepsis progression--not related to device
Frequency: 1 affected / 30 at risk

Adverse event: Oral Bleeding
Serious: yes
Organ System: General disorders
Notes: Patient constantly was biting for over 24 hours after product placement before oral bleeding occurred. Oral bleeding was exacerbated significantly by the heparin drip and other anticoagulation he was on while in the ICU.
Frequency: 1 affected / 30 at risk

Adverse event: Loose teeth
Serious: yes
Organ System: General disorders
Notes: Loose teeth due to prolonged biting, probably NOT related to study device.
Frequency: 1 affected / 30 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin lesion on patient's skin, below nose, but above upper outer lip. Lesion could be due to a herpetic lesion or an underlying skin condition not previously identified/documented. Investigator indicated AE was probably not related to study device.
Frequency: 1 affected / 30 at risk
Study: NCT03328325

Adverse event: Gastric Mass, S/P Wedge resection, GIST Sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 152 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 152 at risk
Study: NCT03328507

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 21 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

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

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 40 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 40 at risk

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

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

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

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 19 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk
Study: NCT03328832

Adverse event: Ecchymosis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 17 affected / 35 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 15 affected / 34 at risk
Study: NCT03329027

Adverse event: Abdominal pain/discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain/discomfort
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal distention/Bloating and/or Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distention/Bloating and/or Flatulence
Frequency: 2 affected / 21 at risk

Adverse event: Sensation of vibration
Serious: no
Organ System: Product Issues
Notes: Sensation of vibration
Frequency: 1 affected / 21 at risk

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

Adverse event: Abdominal pain/discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain/discomfort
Frequency: 2 affected / 22 at risk

Adverse event: Abdominal distention/Bloating and/or Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal distention/Bloating and/or Flatulence
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 1 affected / 22 at risk

Adverse event: Sensation of vibration
Serious: no
Organ System: Product Issues
Notes: Sensation of vibration
Frequency: 2 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary Tract Infection\\Cystitis
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 3 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 1 affected / 24 at risk

Adverse event: Sensation of vibration
Serious: no
Organ System: Product Issues
Notes: Sensation of vibration
Frequency: 3 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 1 affected / 24 at risk
Study: NCT03329131

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 3 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Rash on hands
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Dry skin on feet
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Nail bed changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to Chemotherapy not cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rectal bleeding with bowel movement, not related to cryotherapy
Frequency: 1 affected / 12 at risk

Adverse event: Nail bed loss
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to chemotherapy, not cryotherapy
Frequency: 1 affected / 12 at risk
Study: NCT03329209

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 16 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 16 at risk

Adverse event: Leukocyturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 16 at risk
Study: NCT03329352

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Admitted to ER, was note related to the trial and resolved no sequel
Frequency: 1 affected / 42 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Admitted to ICU. Not related to trial and resolved no sequel
Frequency: 1 affected / 42 at risk

Adverse event: Facial irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Irritations were present whilst using their usual mask so reported as not related and resolved no sequel
Frequency: 2 affected / 42 at risk
Study: NCT03329404

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk
Study: NCT03329599

Adverse event: Post-stroke seizures
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 74 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 74 at risk

Adverse event: Regimen Adjustments
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 74 at risk

Adverse event: Treatment Discontinuation
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 74 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 74 at risk

Adverse event: Gatrointestinal Bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Regimen Adjustments
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 74 at risk
Study: NCT03329989

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 158 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 136 affected / 158 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 158 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 158 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 27 affected / 158 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 26 affected / 158 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 23 affected / 158 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 18 affected / 158 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 17 affected / 158 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 10 affected / 158 at risk

Adverse event: Haemosiderin stain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 158 at risk
Study: NCT03330236

Adverse event: Intraoperative awareness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 779 at risk

Adverse event: Intraoperative awareness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 781 at risk
Study: NCT03330457

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk
Study: NCT03330834

Adverse event: interstitial pneumonia disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Serious Cytokine Release Syndrome causes interstitial pneumonia disease. CTCAE grade 4, possibly drug related.
Frequency: 1 affected / 1 at risk

Adverse event: Serious Cytokine Release Syndrome causes interstitial pneumonia disease.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Uric acid elevation
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: C-reactive protein
Serious: no
Organ System: General disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: White blood cell counts increasing
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: neutrophilic granulocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Toothache
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Albumin decline
Serious: no
Organ System: General disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: swelling of eye
Serious: no
Organ System: Eye disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1, possibly drug not related.
Frequency: 1 affected / 1 at risk
Study: NCT03331042

Adverse event: Nightmare
Serious: no
Organ System: Nervous system disorders
Notes: Nightmare
Frequency: 1 affected / 84 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: somnolence
Frequency: 1 affected / 84 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: asthenia
Frequency: 1 affected / 84 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: somnolence
Frequency: 1 affected / 83 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: upper abdominal pain
Frequency: 1 affected / 83 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: asthenia
Frequency: 1 affected / 83 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: fatigue
Frequency: 1 affected / 83 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: somnolence
Frequency: 1 affected / 83 at risk
Study: NCT03331185

Adverse event: Membrane loss earlier than 4weeks
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-resorbable membrane covering the graft material was monitored during healing. Membrane dehiscence or mobility recorded earlier than 4weeks were recorded. Membrane loss did not affect healing or cause infection or loss of the graft.
Frequency: 7 affected / 14 at risk

Adverse event: Membrane loss earlier than 4weeks
Serious: no
Organ System: Surgical and medical procedures
Notes: Non-resorbable membrane covering the graft material was monitored during healing. Membrane dehiscence or mobility recorded earlier than 4weeks were recorded. Membrane loss did not affect healing or cause infection or loss of the graft.
Frequency: 3 affected / 12 at risk
Study: NCT03331263

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

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Notes: itching at application site (right groin)
Frequency: 1 affected / 10 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Notes: Burning at application site (right groin)
Frequency: 1 affected / 10 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sore Throat
Frequency: 1 affected / 11 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: congestion
Frequency: 1 affected / 11 at risk
Study: NCT03331289

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea and vomiting following subcutaneous administration of exenatide
Frequency: 4 affected / 25 at risk

Adverse event: Genital Mycosis
Serious: no
Organ System: Infections and infestations
Notes: Fungal proliferation in the vaginal tract/urethra
Frequency: 7 affected / 25 at risk

Adverse event: Genital Mycosis
Serious: no
Organ System: Infections and infestations
Notes: Fungal proliferation in the vaginal tract/urethra
Frequency: 4 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea and vomiting following subcutaneous administration of exenatide
Frequency: 2 affected / 25 at risk
Study: NCT03331315

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Transient acute kidney injury, resolved with IV hydration
Frequency: 1 affected / 70 at risk

Adverse event: Procedural haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Estimated Blood Loss \>150cc
Frequency: 2 affected / 68 at risk
Study: NCT03331354

Adverse event: Incarcerated
Serious: yes
Organ System: Social circumstances
Notes: Incarcerated while in follow-up
Frequency: 1 affected / 40 at risk
Study: NCT03331978

Adverse event: Other Adverse Event
Serious: no
Organ System: General disorders
Notes: Includes hospitalizations
Frequency: 3 affected / 122 at risk

Adverse event: Other Adverse Event
Serious: no
Organ System: General disorders
Notes: Includes hospitalizations
Frequency: 3 affected / 123 at risk
Study: NCT03332056

Adverse event: Emergency Department visits
Serious: no
Organ System: General disorders
Notes: Postoperative ED visits. Expected is 12-15%.
Frequency: 3 affected / 35 at risk

Adverse event: Emergency Department visits
Serious: no
Organ System: General disorders
Notes: Postoperative ED visits. Expected is 12-15%.
Frequency: 5 affected / 34 at risk
Study: NCT03332212

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Euglycaemic diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pituitary tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 36 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 36 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 35 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk
Study: NCT03332628

Adverse event: Mild Skin reaction to waterproof tape
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One subject discontinued the study early due to a mild skin reaction to the waterproof medical tape used to secure the occlusive patches on the skin (this subject's data was not included in the analysis)
Frequency: 1 affected / 113 at risk
Study: NCT03333057

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 111 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 114 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 114 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 111 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 111 at risk