TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00649220

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sleep disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Listless
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sleep-related eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

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

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

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

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk
Study: NCT00649428

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Adenocarcimona
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 100 at risk

Adverse event: Athralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 100 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 103 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 103 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 103 at risk

Adverse event: Substance abuser
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 103 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 12 affected / 103 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 103 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 103 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 103 at risk
Study: NCT00650546

Adverse event: abdominal pain along with nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk
Study: NCT00650845

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: This adverse event was deemed not related to the injection of Dotarem®
Frequency: 1 affected / 70 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event was deemed not related to the injection of Dotarem®
Frequency: 1 affected / 70 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: This adverse event was deemed not related to the injection of Dotarem®
Frequency: 1 affected / 70 at risk

Adverse event: Blood creatinin increased
Serious: no
Organ System: Investigations
Notes: This adverse event was deemed possibly related to the injection of Dotarem®
Frequency: 1 affected / 70 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event was deemed not related to the injection of Dotarem®
Frequency: 1 affected / 70 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event was deemed not related to the injection of Dotarem®
Frequency: 1 affected / 70 at risk
Study: NCT00651040

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 16 at risk

Adverse event: worsening of muscles
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 16 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 16 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: general
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 16 at risk

Adverse event: neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 16 at risk

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

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 15 at risk

Adverse event: worsening of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: synkopa
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 15 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 15 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: general
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: gynecological
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk
Study: NCT00651118

Adverse event: dysgusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 207 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 207 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 207 at risk

Adverse event: dysgusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 207 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 207 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 207 at risk

Adverse event: dysgusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 208 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 208 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 208 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: dysgusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 210 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk
Study: NCT00651313

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 77 at risk
Study: NCT00651755

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT00651820

Adverse event: Brain Aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: The 1 SAE (brain aneurysm) was reported as severe and was unrelated to the test articles
Frequency: 1 affected / 28 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound redness (erythema)- Investigator specified Right Arm for 1 subject, which was treated with Vehicle. Investigator did not specify arm for the second subject with erythema, so causative agent could not be determined.
Frequency: 2 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: For 1 subject the Investigator did not specify which arm developed the rash, so unable to determine if Collagenase Santyl or its vehicle was causative agent. For the other subject the Investigator specified that both arms developed a rash.
Frequency: 2 affected / 28 at risk
Study: NCT00651937

Adverse event: Transplant failure
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Transplant failure
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk
Study: NCT00652080

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Application site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 35 at risk

Adverse event: Application site dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Application site exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

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

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Application site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk
Study: NCT00652093

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This single adverse event occurred after darvocet administration.
Frequency: 1 affected / 4 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This single adverse event occurred after opana administration.
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: This single adverse event occurred after placebo administration.
Frequency: 1 affected / 4 at risk
Study: NCT00652145

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Worsening Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Lower back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: increase mucous
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk
Study: NCT00652314

Adverse event: Abnormal Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Infection/Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 62 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Foreign Body / Hypersensitivity Reaction / Allergic Reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Infection/Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 32 affected / 62 at risk

Adverse event: Infection/Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Foreign Body / Hypersensitivity Reaction / Allergic Reaction
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Infection/Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 22 affected / 35 at risk

Adverse event: Tissue Necrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk
Study: NCT00652327

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 41 at risk
Study: NCT00652457

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk
Study: NCT00653133

Adverse event: VASCULAR PUNCTURE
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1324 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: CATHETER SITE LOCAL INFECTION/INFLAMMATION
Frequency: 2 affected / 1324 at risk

Adverse event: motor block
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1324 at risk

Adverse event: VASCULAR PUNCTURE
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 497 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: CATHETER SITE LOCAL INFECTION/INFLAMMATION
Frequency: 2 affected / 497 at risk

Adverse event: motor block
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 497 at risk
Study: NCT00653224

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 293 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 285 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 285 at risk
Study: NCT00653861

Adverse event: Injection side induration
Serious: no
Organ System: General disorders
Frequency: 11 affected / 72 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 11 affected / 72 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 8 affected / 72 at risk

Adverse event: Application site bruise
Serious: no
Organ System: General disorders
Frequency: 6 affected / 72 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Injection side induration
Serious: no
Organ System: General disorders
Frequency: 11 affected / 72 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 12 affected / 72 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 72 at risk

Adverse event: Application site bruise
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 72 at risk