TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01320826

Adverse event: Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 577 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 577 at risk
Study: NCT01321008

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

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

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

Adverse event: Respiratory, Thoracic and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01321177

Adverse event: Psychiatric Hospitalization/illness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 67 affected / 223 at risk

Adverse event: Medical hospitalization/illness
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 223 at risk

Adverse event: Psychiatric Hospitalization/illness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 63 affected / 181 at risk

Adverse event: Medical hospitalization/illness
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 181 at risk
Study: NCT01321437

Adverse event: Hypertension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 11 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 11 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Ageusia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk
Study: NCT01321749

Adverse event: transient sporadic subcutaneous bleeding points
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 51 at risk
Study: NCT01322009

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT01322360

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 50 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 50 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 50 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 50 at risk
Study: NCT01322386

Adverse event: Non-malignant Spinal Cord Tumor
Serious: yes
Organ System: Nervous system disorders
Notes: One subject did have a Serious Adverse Event (SAE) that was not related to the study medication or any study procedure. The SAE was for a Non-Malignant Spinal Cord Tumor. This was identified on February 3,2011 and removed on February 18,2011.
Frequency: 1 affected / 21 at risk
Study: NCT01322607

Adverse event: Esophagitis/Upper Gastrointestinal Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Participant hospitalized for esophagitis/Upper Gastrointestinal Bleed. Proton Pump inhibitor added to medication; eventually cleared by Primary Care Physician to resume participation in the study
Frequency: 1 affected / 11 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: All adverse events other than the one serious event reported were participant falls (expected in this population). No serious injuries reported from falls and all falls were due to losing balance (not fainting or loss of consciousness).
Frequency: 6 affected / 11 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Notes: All adverse events other than the one serious event reported were participant falls (expected in this population). No serious injuries reported from falls and all falls were due to losing balance (not fainting or loss of consciousness).
Frequency: 8 affected / 9 at risk
Study: NCT01322815

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related to GI-4000. Probably related to chemotherapy.
Frequency: 1 affected / 7 at risk

Adverse event: low neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unlikely related to GI-4000. Probably related to chemotherapy.
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: Epitaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 7 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Epitaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Genito-pelvic pain/penetration disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk
Study: NCT01323010

Adverse event: non symptomatic mild hypokalemia at discharge or hospital admission (up to 4 hours post-baseline).
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Non symptomatic mild hypokalemia in 17 patients, 10 in the control group, 7 in the experimental group.

Only 2 patients showed values below 3.1 mEq/L. One patient in the experimental group: 2.8 mEq/L. One patient in the control group: 2.9mEq/L
Frequency: 7 affected / 60 at risk

Adverse event: non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post-baseline)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment).

No patients needed medical intervention.
Frequency: 29 affected / 60 at risk

Adverse event: non symptomatic mild hypokalemia at discharge or hospital admission (up to 4 hours post-baseline).
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Non symptomatic mild hypokalemia in 17 patients, 10 in the control group, 7 in the experimental group.

Only 2 patients showed values below 3.1 mEq/L. One patient in the experimental group: 2.8 mEq/L. One patient in the control group: 2.9mEq/L
Frequency: 10 affected / 59 at risk

Adverse event: non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post-baseline)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Non symptomatic mild hyperglycemia at discharge or hospital admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment).

No patients needed medical intervention.
Frequency: 27 affected / 59 at risk
Study: NCT01323140

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk
Study: NCT01323309

Adverse event: Distress during assessment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 109 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 109 at risk

Adverse event: Distress during assessment
Serious: no
Organ System: General disorders
Frequency: 2 affected / 108 at risk

Adverse event: Distress during assessment
Serious: no
Organ System: General disorders
Frequency: 4 affected / 104 at risk
Study: NCT01323478

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 71 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 71 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 71 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 71 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 71 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 71 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 71 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 71 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 71 at risk
Study: NCT01323582

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worsening of pain while on the medication
Frequency: 1 affected / 26 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Worsening of pain while on the medication
Frequency: 3 affected / 26 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk
Study: NCT01323621

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 252 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 252 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 252 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 252 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Infective tenosynovitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 259 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 259 at risk
Study: NCT01323634

Adverse event: Chronic onstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 259 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 259 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 259 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 259 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 260 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 260 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 260 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 260 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 260 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 260 at risk
Study: NCT01323647

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 84 affected / 470 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 86 affected / 470 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 470 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 157 affected / 470 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 470 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 487 at risk
Study: NCT01323673

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 62 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk
Study: NCT01323777

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: Endophthalmitis (Primary Eye)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Oropharyngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 65 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: Secondary surgical intervention (Primary Eye)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 65 at risk
Study: NCT01323855

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk
Study: NCT01323920

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Notes: 2 participants passed away to Grade 5 GVHD
Frequency: 2 affected / 34 at risk

Adverse event: HHV6/high LFTs
Serious: yes
Organ System: Infections and infestations
Notes: Grade 4 HHV-6 infection and elevated liver function tests
Frequency: 1 affected / 34 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: 2 participants passed away to Grade 5 sepsis
Frequency: 2 affected / 34 at risk

Adverse event: Relapse
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Grade 5 AML relapse complicated by respiratory failure, B.O.S, and pneumonia.
Frequency: 1 affected / 34 at risk