TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02221219

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Extreme Prematurity
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 36 at risk

Adverse event: Free Air in Abdomen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Extreme Prematurity
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 87 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 87 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Cytomegalovirus test
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 87 at risk

Adverse event: Extreme Prematurity
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Extreme Prematurity
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 92 at risk

Adverse event: Free Air in Abdomen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 92 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk
Study: NCT02221284

Adverse event: Cardiac failure acut
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 573 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 573 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: The reasons of events are not determined because assessment findings were insufficient to specify the reason.
Frequency: 1 affected / 573 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 573 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 573 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 166 at risk
Study: NCT02221349

Adverse event: Hyperaesthesia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Burning and painful mouth
Frequency: 1 affected / 14 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Painful mouth, mild and possibly related
Frequency: 1 affected / 14 at risk
Study: NCT02221674

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

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

Adverse event: Junctional ectopic tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Stoma site erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk
Study: NCT02221869

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 104 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 104 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 104 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 104 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 104 at risk

Adverse event: Cataplexy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 104 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 32 at risk

Adverse event: Cataplexy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk
Study: NCT02221947

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT02222168

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Bladder discomfort
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk
Study: NCT02222207

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Visual acuity tests abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 51 at risk

Adverse event: Visual acuity tests abnormal
Serious: no
Organ System: Investigations
Frequency: 5 affected / 51 at risk
Study: NCT02222558

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to study drug, due to muscle injury due to prolonged muscle compression. Lab abnormalities included acute renal failure secondary to rhabdomyolysis, hyperkalemia, high creatinine kinase, and high level of potassium.
Frequency: 1 affected / 8 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

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

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rhabdomyolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT02222610

Adverse event: Metastatic Uveal Melanom
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Worsening of Cataracts
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 8 at risk

Adverse event: Recurrence of Choroidal Melanoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Metastatic Uveal Melanom
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Increased Cup-to-Disc Rratio
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Posterior Capsular Opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 16 at risk

Adverse event: Worsening of Cataracts
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 16 at risk

Adverse event: Acute Chronic Diastolic Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Acute Chronic Renal Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Recurrence of Choroidal Melanoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Worsening of Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ocular Irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Posterior Capsular Opacification
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 16 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 16 at risk

Adverse event: Worsening of Cataracts
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 16 at risk
Study: NCT02222818

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 71 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 71 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 71 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 71 at risk
Study: NCT02222870

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 30 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 30 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 20 affected / 30 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk
Study: NCT02223364

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: 2 in the peripheral nerve block group fell during their hospital stay; one in the ropivacaine periarticular injection group and one in the liposomal bupivacaine periarticular injection group fell after hospital discharge.
Frequency: 2 affected / 50 at risk

Adverse event: Superficial wound infection
Serious: no
Organ System: Infections and infestations
Notes: Six patients, two in each group experienced a superficial wound infection after hospital discharge that required treatment with antibiotics.
Frequency: 2 affected / 50 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Nervous system disorders
Notes: This adverse event occurred after hospital discharge.
Frequency: 2 affected / 50 at risk

Adverse event: Additional surgery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: 2 in the peripheral nerve block group fell during their hospital stay; one in the ropivacaine periarticular injection group and one in the liposomal bupivacaine periarticular injection group fell after hospital discharge.
Frequency: 1 affected / 55 at risk

Adverse event: Superficial wound infection
Serious: no
Organ System: Infections and infestations
Notes: Six patients, two in each group experienced a superficial wound infection after hospital discharge that required treatment with antibiotics.
Frequency: 2 affected / 55 at risk

Adverse event: Rapid Response Team
Serious: no
Organ System: General disorders
Notes: Adverse event occurred during the patients' hospital stay.
Frequency: 1 affected / 55 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: 2 in the peripheral nerve block group fell during their hospital stay; one in the ropivacaine periarticular injection group and one in the liposomal bupivacaine periarticular injection group fell after hospital discharge.
Frequency: 1 affected / 52 at risk

Adverse event: Superficial wound infection
Serious: no
Organ System: Infections and infestations
Notes: Six patients, two in each group experienced a superficial wound infection after hospital discharge that required treatment with antibiotics.
Frequency: 2 affected / 52 at risk

Adverse event: Rapid Response Team
Serious: no
Organ System: General disorders
Notes: Adverse event occurred during the patients' hospital stay.
Frequency: 1 affected / 52 at risk
Study: NCT02223377

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Proportion of patients with respiratory depression: patients needing naloxone treatment.
Frequency: 11 affected / 199 at risk

Adverse event: Severe itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured as visual analogue scale (VAS)\>5/10.
Frequency: 2 affected / 199 at risk

Adverse event: Severe sedation
Serious: no
Organ System: Nervous system disorders
Notes: Proportion of patients with severe sedation: measured as Ramsay sedation score \>3/6.
Frequency: 5 affected / 199 at risk

Adverse event: Respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Proportion of patients with respiratory depression: patients needing naloxone treatment.
Frequency: 10 affected / 202 at risk

Adverse event: Severe itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: measured as visual analogue scale (VAS)\>5/10.
Frequency: 5 affected / 202 at risk

Adverse event: Severe sedation
Serious: no
Organ System: Nervous system disorders
Notes: Proportion of patients with severe sedation: measured as Ramsay sedation score \>3/6.
Frequency: 8 affected / 202 at risk
Study: NCT02223429

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: High Blood Pressure prior to Drug Administration
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache prior to Drug Administration
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nasal Spray Strength Intolerance
Serious: no
Organ System: Product Issues
Notes: Participants reported that the vasopressin nasal spray was too strong. The brand was subsequently changed.
Frequency: 2 affected / 16 at risk

Adverse event: High Blood Pressure prior to Drug Administration
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 16 at risk
Study: NCT02223520

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 147 at risk

Adverse event: Nose irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 160 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 160 at risk

Adverse event: Retained placenta or membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 160 at risk