TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01575899

Adverse event: Visited our emergency room
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Vomiting during eradication, visited our ER, improved after symptomatic treatment, then the case was loss in follow up.
Frequency: 1 affected / 10 at risk

Adverse event: Nausea / Hiccough
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hiccough and/or sensation of nausea
Frequency: 4 affected / 73 at risk

Adverse event: Loose stool / Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea or loose stool passage.
Frequency: 3 affected / 73 at risk

Adverse event: Change in appetite / Bitter sensation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bitter sensation in tongue, change in taste or appetite.
Frequency: 2 affected / 73 at risk

Adverse event: Abdominal fullness / Flatus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Flatus, abdominal fullness and gas passage.
Frequency: 1 affected / 73 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Poor sleep.
Frequency: 1 affected / 73 at risk

Adverse event: Nausea / Hiccough
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hiccough and/or sensation of nausea
Frequency: 4 affected / 73 at risk

Adverse event: Loose stool / Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea or loose stool passage.
Frequency: 1 affected / 73 at risk

Adverse event: Change in appetite / Bitter sensation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bitter sensation in tongue, change in taste or appetite.
Frequency: 4 affected / 73 at risk

Adverse event: Abdominal fullness / Flatus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Flatus, abdominal fullness and gas passage.
Frequency: 3 affected / 73 at risk

Adverse event: Nausea / Hiccough
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hiccough and/or sensation of nausea
Frequency: 4 affected / 62 at risk

Adverse event: Loose stool / Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea or loose stool passage.
Frequency: 8 affected / 62 at risk

Adverse event: Abdominal fullness / Flatus
Serious: no
Organ System: Gastrointestinal disorders
Notes: Flatus, abdominal fullness and gas passage.
Frequency: 4 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Poor sleep.
Frequency: 4 affected / 62 at risk
Study: NCT01576003

Adverse event: Hospitalization for fever in a patient with a central line
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Central Venous Catheter (CVC) dislodged
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rash Maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Viral Illness
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Hospitalization for fever in a patient with a central line
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Respiratory syncytial virus (RSV)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diaper Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT01576120

Adverse event: Adverse event related to the preparation
Serious: no
Organ System: Gastrointestinal disorders
Notes: adverse events were reported as related to the the preparation such as vomiting and nausea
Frequency: 6 affected / 21 at risk

Adverse event: Adverse event not related to study procedure
Serious: no
Organ System: Gastrointestinal disorders
Notes: adverse events were reported as not related to the study procedure such as fever and headache
Frequency: 3 affected / 21 at risk

Adverse event: Adverse event related to the preparation
Serious: no
Organ System: Gastrointestinal disorders
Notes: adverse events were reported as related to the the preparation such as vomiting and nausea
Frequency: 2 affected / 19 at risk

Adverse event: Adverse event not related to study procedure
Serious: no
Organ System: Gastrointestinal disorders
Notes: adverse events were reported as not related to the study procedure such as fever and headache
Frequency: 2 affected / 19 at risk
Study: NCT01576276

Adverse event: Drug related reactions
Serious: no
Organ System: Surgical and medical procedures
Notes: Drug related reactions to morphine and ketorolac, including feeling nauseous, spacey, and drugged.
Frequency: 5 affected / 22 at risk

Adverse event: Drug related reactions
Serious: no
Organ System: Surgical and medical procedures
Notes: Drug related reactions to morphine and ketorolac, including feeling nauseous, spacey, and drugged.
Frequency: 1 affected / 29 at risk
Study: NCT01576471

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Vein disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 125 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 125 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 125 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Abscess intestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 125 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 125 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 125 at risk
Study: NCT01576536

Adverse event: acute right groin pain
Serious: yes
Organ System: General disorders
Notes: Study volunteer experienced acute right groin pain. He was taken to the Emergency Department treated with painkillers--had normal X-ray and MRI showing normal appearance of hip. Discharged from ED on analgesics--ED diagnosis "acute right groin pain".
Frequency: 1 affected / 117 at risk
Study: NCT01576549

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk
Study: NCT01576575

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 12 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 14 affected / 21 at risk

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 13 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 10 affected / 18 at risk

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

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 11 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 11 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 12 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Notes: Adverse Event Reporting Description by Arms/Groups are combined as individual results not available. Adverse events all due to buprenorphine not pretreatments
Frequency: 8 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 13 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk
Study: NCT01576588

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Febrile neutropenia
Frequency: 3 affected / 25 at risk

Adverse event: Extrasystolia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Orfarin overdosage
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 25 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Diarea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Upper pulmonary infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Left femur cervical stress fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

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

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hypertention
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 25 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Chest discomfort/pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 25 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk
Study: NCT01576705

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 44 at risk

Adverse event: Congenital, familial and genetic disorders
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 43 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Skin and subcutnaeous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 43 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 43 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 43 at risk

Adverse event: Neoplasm begign, maligant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 43 at risk

Adverse event: Neoplasms begnin, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk
Study: NCT01576718

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 106 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 107 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 107 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 107 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 106 at risk
Study: NCT01576783

Adverse event: ENT Symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 29 affected / 189 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 189 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 189 at risk

Adverse event: Skin/Limb Symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 189 at risk

Adverse event: Behavioral Symptoms
Serious: no
Organ System: Social circumstances
Notes: Includes fussiness, temper tantrums, moodiness, etc.
Frequency: 22 affected / 189 at risk

Adverse event: Misc Symptoms
Serious: no
Organ System: Immune system disorders
Notes: Multi-symptom illnesses reported by caregivers which typically included more than 1 body system
Frequency: 35 affected / 189 at risk

Adverse event: ENT Symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 33 affected / 188 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 188 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 188 at risk

Adverse event: Skin/Limb Symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 188 at risk

Adverse event: Behavioral Symptoms
Serious: no
Organ System: Social circumstances
Notes: Includes fussiness, temper tantrums, moodiness, etc.
Frequency: 19 affected / 188 at risk

Adverse event: Misc Symptoms
Serious: no
Organ System: Immune system disorders
Notes: Multi-symptom illnesses reported by caregivers which typically included more than 1 body system
Frequency: 41 affected / 188 at risk
Study: NCT01576809

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk
Study: NCT01576939

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 30 at risk
Study: NCT01576952

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 169 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 169 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 169 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 169 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 85 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 85 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 85 at risk
Study: NCT01577160

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 353 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 353 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 353 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 353 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 353 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 353 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 353 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 353 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 353 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 353 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 353 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 353 at risk