TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00052442

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 16 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 16 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Neutropenia & Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: General Disorders
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 27 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neutropenia & Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 15 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Neutropenia & Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 15 at risk

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

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk
Study: NCT00052962

Adverse event: Ileus, wound infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Lipase gr
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fistula intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Post-op ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Wound infection (superficial)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
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: ALT/AST
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: UTI: pyelonephritis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pleural effusion post op
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Partial small bowel obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

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

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

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abd pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bilateral pleural effusion, bibasilar atelectasis, pelvic fluid
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: ALT/AST
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 14 at risk
Study: NCT00053014

Adverse event: Infection and dyspnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT00053677

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 58 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 58 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 58 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 8 affected / 58 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 19 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT00053989

Adverse event: DBE/FTE
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: died before absolute neutrophil count recovery (DBE) or survived to day +28 without absolute neutrophil count recovery (FTE)
Frequency: 3 affected / 41 at risk

Adverse event: acute GVHD grade III-IV
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 41 at risk
Study: NCT00054327

Adverse event: Melena/GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Elevated Bilirubin associated with graft versus host disease (GVHD)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mood alteration-anxiety, agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Death not associated with CTCAE term - Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT00054639

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 46 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 and 2
Frequency: 23 affected / 46 at risk

Adverse event: Thrompbocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grades 1 and 2
Frequency: 8 affected / 46 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grades 1 and 2
Frequency: 3 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grades 1 and 2
Frequency: 17 affected / 46 at risk

Adverse event: Odema
Serious: no
Organ System: Eye disorders
Notes: Grades 1 and 2
Frequency: 9 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grades 1 and 2
Frequency: 9 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Grades 1 and 2
Frequency: 5 affected / 46 at risk
Study: NCT00055692

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 46 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 46 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 46 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Increased AST
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Increased ALT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Increased alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Increased bilirubin
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 46 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 46 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 46 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 46 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 46 at risk

Adverse event: Increased AST
Serious: no
Organ System: Investigations
Frequency: 9 affected / 46 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Investigations
Frequency: 8 affected / 46 at risk

Adverse event: Increased alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 46 at risk

Adverse event: Increased bilirubin
Serious: no
Organ System: Investigations
Frequency: 7 affected / 46 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk
Study: NCT00056498

Adverse event: increased auditory hallucinations
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was hospitalized due to an increase in intensity of auditory hallucinations including commands to harm self and need for hospitalization. Considered to be moderate in severity, and remotely study drug and concomitant drug related.
Frequency: 1 affected / 30 at risk

Adverse event: gastrointestinal symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject c/o of diarrhea, nausea, and vomiting with a history of constipation and admitted to the hospital. Subject was treated for renal failure secondary to nausea and vomiting. Considered to be severe and possibly drug related.
Frequency: 1 affected / 35 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject reported to the ER c/o racing pulse and thoughts and experiencing a "panic attack". After overnight observation, patient reports symptoms subsided and all labwork was normal. Determined to be severe and remotely study drug related.
Frequency: 1 affected / 35 at risk
Study: NCT00056550

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hemorrhage NOS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Fracture Trauma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Procedural pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk
Study: NCT00056862

Adverse event: Sarcoidosis development
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Atrial fibrillation (off treatment),
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Melanoma and death
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Mastoiditis complicated by myocardial infarction, heart failure, coronary bypass surgery and death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Heroin overdose leading to death
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 27 at risk

Adverse event: Severe hemolysis requiring transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk
Study: NCT00057551

Adverse event: moderate burden
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 200 at risk

Adverse event: moderate burden
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 195 at risk

Adverse event: moderate burden
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 96 at risk
Study: NCT00057577

Adverse event: Death (any cause)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 227 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 227 at risk

Adverse event: Psychiatric Hospitalizations
Serious: yes
Organ System: Psychiatric disorders
Frequency: 15 affected / 227 at risk

Adverse event: Medical Hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 30 affected / 227 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 227 at risk

Adverse event: Motor Vehicle Accidents (MVA)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 227 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 227 at risk

Adverse event: Death (any cause)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 225 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 225 at risk

Adverse event: Psychiatric Hospitalizations
Serious: yes
Organ System: Psychiatric disorders
Frequency: 28 affected / 225 at risk

Adverse event: Medical Hospitalizations
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 225 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 225 at risk

Adverse event: Motor Vehicle Accidents (MVA)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 225 at risk
Study: NCT00057681

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Admission to the hospital or prolongation of a hospital stay results because of the adverse event.
Frequency: 5 affected / 137 at risk

Adverse event: Event requiring intervention to prevent permanent impairment or damage
Serious: yes
Organ System: Psychiatric disorders
Notes: A condition that requires medical or surgical intervention to preclude permanent impairment or damage to a subject.
Frequency: 1 affected / 137 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Admission to the hospital or prolongation of a hospital stay results because of the adverse event.
Frequency: 4 affected / 139 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Admission to the hospital or prolongation of a hospital stay results because of the adverse event.
Frequency: 5 affected / 103 at risk
Study: NCT00058123

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 45 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Elevated Alanine Transferase
Serious: no
Organ System: Investigations
Frequency: 13 affected / 45 at risk

Adverse event: Granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 45 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 45 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 45 at risk