TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01013597

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Death, NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Hemorrhage/bleeding
Serious: yes
Organ System: General disorders
Notes: neck lesion
Frequency: 1 affected / 13 at risk

Adverse event: Colitis, infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Other
Serious: yes
Organ System: Nervous system disorders
Notes: Subdural hematoma after fall
Frequency: 1 affected / 13 at risk

Adverse event: Pleural effusion, non-malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk
Study: NCT01013753

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk
Study: NCT01013792

Adverse event: Ulcer/foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unexpected death in his sleep
Frequency: 1 affected / 14 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper respiratory infection
Frequency: 3 affected / 14 at risk

Adverse event: Wound/Skin Infection
Serious: no
Organ System: Infections and infestations
Notes: Infection/Cellulitis in wound or periwound skin
Frequency: 4 affected / 14 at risk

Adverse event: Pain, Trauma, Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 14 at risk

Adverse event: Phlebitis, Edema, Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Surgical resection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 14 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Ischemic event with associate foot infection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk

Adverse event: Ulcer/foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Renal failure, resulting in hemodialysis
Frequency: 1 affected / 16 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Upper respiratory infection
Frequency: 3 affected / 16 at risk

Adverse event: Wound/Skin Infection
Serious: no
Organ System: Infections and infestations
Notes: Infection/Cellulitis in wound or periwound skin
Frequency: 7 affected / 16 at risk

Adverse event: Pain, Trauma, Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 16 at risk

Adverse event: Phlebitis, Edema, Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 16 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Dizzy spells
Frequency: 1 affected / 16 at risk

Adverse event: Surgical resection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 16 at risk
Study: NCT01013870

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 28 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: change in urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: change in urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: not feeling well
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk
Study: NCT01014143

Adverse event: Upset stomach - non related to product use
Serious: no
Organ System: Social circumstances
Notes: All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product use.
Frequency: 1 affected / 26 at risk

Adverse event: Sinus headache - non related to product use
Serious: no
Organ System: Social circumstances
Notes: All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product use.
Frequency: 1 affected / 26 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Social circumstances
Notes: All events resolved in the same day to 3 days after reporting. Adverse events reported in this study were determined not to be related to study product use.
Frequency: 1 affected / 26 at risk
Study: NCT01014390

Adverse event: Cholangitis/fever
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 187 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 187 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 187 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 187 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 187 at risk

Adverse event: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 187 at risk
Study: NCT01014533

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk
Study: NCT01014624

Adverse event: Eyelid oedema
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: Adominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Increased tendency to bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Adominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk
Study: NCT01014689

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 191 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 191 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 187 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 187 at risk
Study: NCT01014871

Adverse event: Dental discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

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

Adverse event: Facial paresis
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

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

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

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

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

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dental discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

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

Adverse event: Facial paresis
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Injection site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

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

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

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

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk
Study: NCT01015170

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant fell and hospitalized for head injury
Frequency: 1 affected / 454 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ER visit for wheezing
Frequency: 1 affected / 454 at risk

Adverse event: Mental Health issues
Serious: yes
Organ System: Psychiatric disorders
Notes: ER visit for mental health issues
Frequency: 2 affected / 454 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: ER visit for Chest pain
Frequency: 1 affected / 454 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ER visit for Pancreatitis
Frequency: 1 affected / 454 at risk

Adverse event: Loss of consciousess
Serious: yes
Organ System: Nervous system disorders
Notes: Loss of consciousness
Frequency: 2 affected / 454 at risk
Study: NCT01015534

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 \<500 - 200 mm3. Grade 4 \<200/mm3
Frequency: 11 affected / 28 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 \<2000 - 1000/mm3
Frequency: 1 affected / 28 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 \<50,000 - 25,000/mm3. Grade 4 \<25,000/mm3
Frequency: 3 affected / 28 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 \<1000 - 500/mm3
Frequency: 1 affected / 28 at risk

Adverse event: Nausea-Vomiting
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Grade 3 ≥6 episodes in 24 hrs; IV fluids, indicated

≥24 hrs
Frequency: 1 affected / 28 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 \< Low limit of normal (LLN) - 800/mm3. Grade 2 \<800 - 500/mm3.
Frequency: 5 affected / 28 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 \<LLN-75,000/mm3. Grade 2 \<75,000-50,000/mm3.
Frequency: 3 affected / 28 at risk

Adverse event: Alanine aminotransferase - Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Alanine aminotransferase Grade 1 \> Upper limit of normal (ULN) - 2.5 x ULN Aspartate aminotransferase Grade 1 \> ULN - 2.5 x ULN
Frequency: 3 affected / 28 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 \<500 - 200 mm3. Grade 4 \<200/mm3
Frequency: 6 affected / 27 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 \<1000 - 500/mm3
Frequency: 1 affected / 27 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 \< Low limit of normal (LLN) - 800/mm3. Grade 2 \<800 - 500/mm3.
Frequency: 11 affected / 27 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 \<LLN-75,000/mm3. Grade 2 \<75,000-50,000/mm3.
Frequency: 1 affected / 27 at risk

Adverse event: Alanine aminotransferase - Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Alanine aminotransferase Grade 1 \> Upper limit of normal (ULN) - 2.5 x ULN Aspartate aminotransferase Grade 1 \> ULN - 2.5 x ULN
Frequency: 1 affected / 27 at risk
Study: NCT01015560

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 42 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 42 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 42 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 42 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 42 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 42 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 42 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 42 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 42 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 42 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 42 at risk
Study: NCT01015586

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Active suicidal ideation with plan to overdose on medications
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 21 at risk

Adverse event: Erythema / skin discoloration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Active suicidal ideation with plan to overdose on medications
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalization (medical) after assault
Serious: yes
Organ System: Surgical and medical procedures
Notes: Neurosurgical evacuation of epidural hematoma, intensive care required after serious assault
Frequency: 1 affected / 22 at risk

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

Adverse event: Erythema / skin discoloration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk
Study: NCT01015638

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 19 at risk