TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01673282

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 153 at risk

Adverse event: Drug ineffective
Serious: no
Organ System: General disorders
Notes: Adverse event terminology as reported by the investigator.
Frequency: 9 affected / 153 at risk

Adverse event: Off label use
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse event terminology as reported by the investigator.
Frequency: 15 affected / 153 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Overdose was defined as any Vimpat dose that was higher than the maximum approved dose of 400 mg/day. Adverse event terminology as reported by the investigator.
Frequency: 15 affected / 153 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 158 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 158 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 158 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 158 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 158 at risk

Adverse event: Adverse event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 158 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 158 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 158 at risk

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

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 158 at risk

Adverse event: Drug ineffective
Serious: no
Organ System: General disorders
Notes: Adverse event terminology as reported by the investigator.
Frequency: 2 affected / 158 at risk

Adverse event: Off label use
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse event terminology as reported by the investigator.
Frequency: 7 affected / 158 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Overdose was defined as any Vimpat dose that was higher than the maximum approved dose of 400 mg/day. Adverse event terminology as reported by the investigator.
Frequency: 7 affected / 158 at risk
Study: NCT01673347

Adverse event: Allograft failure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: dissolution of allograft and obliteration of the MTP joint space
Frequency: 7 affected / 24 at risk
Study: NCT01673490

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 59 at risk
Study: NCT01673620

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk
Study: NCT01674569

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac 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: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Gastrointestinal reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Alanine amino transferase elevation
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 35 at risk

Adverse event: Aspartate amino transferase elevation
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 35 at risk

Adverse event: decrease body weight
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: muscle spasma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 35 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 35 at risk
Study: NCT01675011

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01675050

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

Adverse event: Somnolence (Drowsiness)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cold Sweats
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Restless Sleeping Pattern
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Trouble Sleeping (Insomnia)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Somnolence (Drowsiness)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT01675154

Adverse event: Increased urgency of passing stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

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

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

Adverse event: Pancreatitis.
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 2 at risk
Study: NCT01675479

Adverse event: Epithelial ingrowth requiring non refractive intervention
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: Decrease in BSCVA
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: Severe glare
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk
Study: NCT01675531

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Severity was severe and causality was not suspected with investigational drug(Oxycodone/Naloxone).

Action taken was not changed to dose of investigational drug. However, Eventually, patient was withdrawal to study by herself.
Frequency: 1 affected / 72 at risk

Adverse event: Mental inpairment
Serious: yes
Organ System: Nervous system disorders
Notes: Severity was mild and causality was not suspected. Action taken of study drug was not changed. The patient was completed to study by the end without drop out.
Frequency: 1 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 72 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 72 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 72 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 72 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 72 at risk
Study: NCT01675778

Adverse event: Oxygen saturation level < 92%
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hydromorphone could cause respiratory depression, which could lead to low oxygen saturation level.
Frequency: 1 affected / 174 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hydromorphone could cause nausea.
Frequency: 33 affected / 174 at risk

Adverse event: Vomit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hydromorphone could cause vomit.
Frequency: 4 affected / 174 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hydromorphone could cause skin itching.
Frequency: 15 affected / 174 at risk
Study: NCT01675960

Adverse event: Increased sleepiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT01676012

Adverse event: vocal cord pathology
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: After sedation patient was unable to ventilate adequate due to vocal cord pathology. Study procedures were not started.
Frequency: 1 affected / 29 at risk

Adverse event: prolonged hospitalisiation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: After study procedures larynx was lasered. Due to that procedure patient developed oedema wich coused a inspiratory stridor.
Frequency: 1 affected / 29 at risk
Study: NCT01676116

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 291 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 291 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 291 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 291 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 291 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 291 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 291 at risk

Adverse event: Pituitary tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 291 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 291 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 291 at risk

Adverse event: Thrombectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 291 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 291 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 291 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 291 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 291 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 291 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 291 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 145 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 145 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 145 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 145 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 145 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 145 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 145 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 145 at risk
Study: NCT01676701

Adverse event: Gastric infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk
Study: NCT01676831

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 8 at risk

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

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

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk
Study: NCT01676896

Adverse event: Hospital stay > 24 hours
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: child was hospitalized for greater than 24 hours to manage asthma episode
Frequency: 1 affected / 96 at risk

Adverse event: Hospital stay > 24 hours
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: child was hospitalized for greater than 24 hours to manage asthma episode
Frequency: 1 affected / 100 at risk
Study: NCT01676909

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: Medical or mental health hospitalizations reported during assessment, over the phone, or in group.
Frequency: 39 affected / 124 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: General disorders
Notes: Medical or mental health hospitalizations reported during assessment, over the phone, or in group.
Frequency: 30 affected / 118 at risk
Study: NCT01677182

Adverse event: Psychiatric symptom
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 184 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 184 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 169 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 182 at risk

Adverse event: Hypomania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 182 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 182 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 182 at risk
Study: NCT01677195

Adverse event: Indigestion, reflux, heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 71 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 71 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 71 at risk

Adverse event: Indigestion, reflux, heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 83 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 83 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 83 at risk

Adverse event: Indigestion, reflux, heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk
Study: NCT01677286

Adverse event: Hypervolaemia
Serious: yes
Organ System: Cardiac disorders
Notes: SOB, edema
Frequency: 3 affected / 25 at risk

Adverse event: Sun hypersensitivity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Burns/desquamation induced by sun hypersensitivity
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal distension
Frequency: 1 affected / 25 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Orthopedic issues
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 25 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular trachycardia
Frequency: 1 affected / 25 at risk

Adverse event: Hip disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Skin disruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 25 at risk

Adverse event: GI disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 25 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 25 at risk
Study: NCT01677312

Adverse event: Bleeding and fever
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk
Study: NCT01677767

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Notes: General Disorders And Administrations
Frequency: 1 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: General Disorders And Administrations
Frequency: 2 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 124 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Peritonitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: General Disorders And Administrations
Frequency: 4 affected / 124 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: General Disorders And Administrations
Frequency: 7 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 124 at risk