TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02858583

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: intraventricular hemorrhage garde 3 and 4
Frequency: 1 affected / 11 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: intraventricular hemorrhage garde 3 and 4
Frequency: 2 affected / 14 at risk
Study: NCT02858713

Adverse event: Worsening of chronic obstructive pumonary disease (COPD)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Associated to accidentally inhaling gas from canister containing Cal/BD foam
Frequency: 1 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated liver enzymes after treatment with methotrexate. Not related to use of Cal/BD foam
Frequency: 2 affected / 66 at risk

Adverse event: Skin manifestations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 11 different skin manifestations not directly related to use of Enstilar
Frequency: 8 affected / 66 at risk

Adverse event: various musculoskelatal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to the use of Cal/BD foam
Frequency: 4 affected / 66 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Notes: Fainting not related to use of Cal/BD foam
Frequency: 1 affected / 66 at risk

Adverse event: Lung and skin infections
Serious: no
Organ System: Infections and infestations
Notes: Not related to the use of Cal/BD foam
Frequency: 4 affected / 66 at risk

Adverse event: Infection in knee prosthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Infection in knee prosthesis. Not Associated with the use of Cal/BD foam.
Frequency: 1 affected / 68 at risk

Adverse event: relapse of carcinoma in situ of the glottis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to use of Cal/BD foam
Frequency: 1 affected / 68 at risk

Adverse event: Nausea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated liver enzymes after treatment with methotrexate. Not related to use of Cal/BD foam
Frequency: 1 affected / 68 at risk

Adverse event: Elevated creatinin levels
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 68 at risk

Adverse event: Skin manifestations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 11 different skin manifestations not directly related to use of Enstilar
Frequency: 8 affected / 68 at risk

Adverse event: various musculoskelatal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to the use of Cal/BD foam
Frequency: 4 affected / 68 at risk

Adverse event: Lung and skin infections
Serious: no
Organ System: Infections and infestations
Notes: Not related to the use of Cal/BD foam
Frequency: 4 affected / 68 at risk
Study: NCT02859415

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

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

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

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

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

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

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

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

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 2 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT02861118

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk
Study: NCT02861131

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pneumonia leading to death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 100 at risk

Adverse event: Nausea or Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 100 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 100 at risk

Adverse event: Foul, salty or metallic taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 100 at risk

Adverse event: Significant Residual Neuromuscular Paralysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Significant residual Neuromuscular paralysis putting oxygenation and ventilation at risk
Frequency: 2 affected / 100 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 100 at risk

Adverse event: Nausea or Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 100 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 100 at risk

Adverse event: Foul, salty or metallic taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 100 at risk
Study: NCT02862106

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Mouth ulcers
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 178 at risk

Adverse event: Glomerulonephritis chronic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 178 at risk

Adverse event: Severe chronic hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 178 at risk

Adverse event: Acute exacerbation of Chronic hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 178 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 178 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 178 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 178 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 178 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 178 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 178 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 178 at risk

Adverse event: Leukocytes in urine positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 178 at risk

Adverse event: Elevated transaminase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 178 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 178 at risk

Adverse event: Mouth ulcers
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 178 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 178 at risk

Adverse event: Gingival swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 178 at risk
Study: NCT02862171

Adverse event: Stab wound, ankle fracture, fibula fracture, muscle strain, soft tissue injury, thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 941 at risk

Adverse event: Meningitis tuberculous, Pyelonephritis, Sepsis, vuval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 941 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 941 at risk

Adverse event: Hypertension, Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 941 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 941 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 941 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 941 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 941 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 941 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection, genital infection female, vulvovaginitis, genitourinary tract gonococcal infection, trichomoniasis, bacterial vaginosis, vulvovaginal candidiasis, viral rhinitis
Frequency: 462 affected / 941 at risk

Adverse event: Reproductive system
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Cervical dysplasia, vulvovaginal pruritus, dysmenorrhoea, pelvic pain
Frequency: 197 affected / 941 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 941 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 941 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 941 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 941 at risk
Study: NCT02862210

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 9 at risk
Study: NCT02862574

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Fractured sacrum
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT02862600

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Exacerbation of congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Notes: The subject had a history of CHF which was exacerbated during the study. The investigator classified the event as unrelated to study drug.
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: atrial fibrillation recurrence
Serious: yes
Organ System: Cardiac disorders
Notes: A subject with a history of AF had a recurrent event during the trial. The subject was admitted and the condition resolved. The investigator classified the event as unrelated to study drug.
Frequency: 1 affected / 35 at risk

Adverse event: recurrence of atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: A subject with a history of AF had a recurrent event during the trial. The subject was admitted and the condition resolved. The investigator classified the event as unrelated to study drug.
Frequency: 1 affected / 35 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk
Study: NCT02862730

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI upset includes: nausea, stomach cramps, belching, sour stomach.
Frequency: 3 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: mild edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: minor pain and redness at IV or infusion site
Frequency: 1 affected / 23 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI upset includes: nausea, stomach cramps, belching, sour stomach.
Frequency: 4 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: mild edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: minor pain and redness at IV or infusion site
Frequency: 2 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at a sensor insertion site or from heart rate monitor.
Frequency: 1 affected / 22 at risk

Adverse event: device induced symptomatic hypoglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI upset includes: nausea, stomach cramps, belching, sour stomach.
Frequency: 1 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at a sensor insertion site or from heart rate monitor.
Frequency: 1 affected / 22 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at a sensor insertion site or from heart rate monitor.
Frequency: 1 affected / 25 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk
Study: NCT02863263

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

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

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pyuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The causal relationship was assessed to be unrelated to the investigational device.
Frequency: 1 affected / 2 at risk