TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00003224

Adverse event: Esophageal spasm, Grade 3
Serious: yes
Organ System: Gastrointestinal disorders
Notes: This occurred in one patient on group 3, whose vaccine incorporated QS-21.
Frequency: 1 affected / 12 at risk

Adverse event: grade 1-2 skin toxicity, especially pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: vaccine site, typically transient.
Frequency: 9 affected / 12 at risk

Adverse event: skin, other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 12 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 12 at risk

Adverse event: Other pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: other gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: other neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hematological
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: grade 1-2 skin toxicity, especially pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: vaccine site, typically transient.
Frequency: 3 affected / 10 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: other gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: other neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk
Study: NCT00003270

Adverse event: DBE/FTE
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: DBE: Died before engraftment (did not achieve absolute neutrophil recovery) FTE: Failed to engraft (survived to at least day +42 without absolute neutrophil recovery
Frequency: 5 affected / 20 at risk

Adverse event: Severe Acute graft-versus-host disease
Serious: no
Organ System: Immune system disorders
Notes: Overall grade III-IV acute graft-versus-host disease
Frequency: 5 affected / 20 at risk
Study: NCT00003483

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Notes: The Allergic reaction/hypersensitivity (including drug fever) was possibly related to Antineoplaston therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Infection (documented clinically): Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Notes: The Infection (documented clinically): Skin (cellulitis) was not related to Antineoplaston therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: The Confusion was not related to Antineoplaston therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: The Somnolence/depressed level of consciousness was not related to Antineoplaston therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Pain: Head/headache
Serious: yes
Organ System: Nervous system disorders
Notes: The Pain: Head/headache was not related to Antineoplaston therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Central Venous Catheter Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Infection (documented clinically): Mucosa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Infection (documented clinically): Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Infection (documented clinically): Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Opportunistic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk
Study: NCT00003492

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Edema/Fluid retention
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 9 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9 at risk
Study: NCT00003645

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 30 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 30 at risk

Adverse event: Decreased Libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 30 at risk

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

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 30 at risk
Study: NCT00003659

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Pulmonary, other Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Infection with grade 3/4 neut
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 36 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 36 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 36 at risk
Study: NCT00003816

Adverse event: 1 yr TRM
Serious: yes
Organ System: Investigations
Notes: death due to transplant related causes before 1 year after BMT
Frequency: 11 affected / 55 at risk

Adverse event: acute graft-versus-host disease
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: overall grade II to IV acute graft versus host disease
Frequency: 25 affected / 55 at risk

Adverse event: 1 yr TRM
Serious: yes
Organ System: Investigations
Notes: death due to transplant related causes before 1 year after BMT
Frequency: 10 affected / 69 at risk

Adverse event: acute graft-versus-host disease
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: overall grade II to IV acute graft versus host disease
Frequency: 35 affected / 69 at risk

Adverse event: 1 yr TRM
Serious: yes
Organ System: Investigations
Notes: death due to transplant related causes before 1 year after BMT
Frequency: 62 affected / 199 at risk

Adverse event: acute graft-versus-host disease
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: overall grade II to IV acute graft versus host disease
Frequency: 100 affected / 199 at risk

Adverse event: 1 yr TRM
Serious: yes
Organ System: Investigations
Notes: death due to transplant related causes before 1 year after BMT
Frequency: 6 affected / 23 at risk

Adverse event: acute graft-versus-host disease
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: overall grade II to IV acute graft versus host disease
Frequency: 6 affected / 23 at risk

Adverse event: 1 yr TRM
Serious: yes
Organ System: Investigations
Notes: death due to transplant related causes before 1 year after BMT
Frequency: 4 affected / 15 at risk

Adverse event: acute graft-versus-host disease
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: overall grade II to IV acute graft versus host disease
Frequency: 9 affected / 15 at risk
Study: NCT00003830

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 2788 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2788 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2788 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2788 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 5 affected / 2800 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2800 at risk
Study: NCT00003875

Adverse event: Hospitalization for pulmonary embolus (likely from Hickman line)
Serious: yes
Organ System: Vascular disorders
Notes: Transplant toxicity. Note: No SAEs in IL-2 portion of the study.
Frequency: 1 affected / 29 at risk

Adverse event: Prolonged Hospitalization (34 days) for hyperbilirubinemia
Serious: yes
Organ System: Investigations
Notes: Transplant toxicity. Note: No SAEs in IL-2 portion of the study. Possible autoimmune hemolysis or syngeneic GVHD and severe skin desquamation
Frequency: 1 affected / 29 at risk

Adverse event: Hospitalization for infection
Serious: yes
Organ System: Infections and infestations
Notes: Transplant toxicity. Note: No SAEs in IL-2 portion of the study.
Frequency: 2 affected / 29 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Transplant toxicity. Note: No SAEs in IL-2 portion of the study.
Frequency: 1 affected / 29 at risk

Adverse event: Myelosuppression
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Transplant toxicity
Frequency: 29 affected / 29 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI Common Toxicity Version 3 - Toxicity to IL-2 Therapy. Only 21 of 29 transplanted patients got IL-2 therapy.
Frequency: 4 affected / 21 at risk
Study: NCT00004143

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cardiac ischemia / infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Parainfluenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk
Study: NCT00004146

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: reversible vision loss
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 55 at risk

Adverse event: hemorrhage-other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 55 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 55 at risk
Study: NCT00004412

Adverse event: Vaso-occlusive crisis (VOC))
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 11 at risk

Adverse event: Head & Eye Pain
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Chest Pain , SOB
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Vaso-occlusive crisis (VOC))
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 15 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 15 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Clotted Portacath
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chronic Limb Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Ulcer Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Possible Celluitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pre-existing Osteomyelitis of Left Foot
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pleural effusion and Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk
Study: NCT00004418

Adverse event: Death
Serious: yes
Organ System: Endocrine disorders
Notes: Subject had profound adrenal crisis and died
Frequency: 1 affected / 126 at risk

Adverse event: Adrenocortical insufficiency acute
Serious: yes
Organ System: Endocrine disorders
Notes: Two events of adrenal crisis
Frequency: 2 affected / 126 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low platelet count defined as \<80, 000
Frequency: 1 affected / 126 at risk
Study: NCT00004445

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk
Study: NCT00004562

Adverse event: Death from all causes
Serious: yes
Organ System: Cardiac disorders
Frequency: 150 affected / 1101 at risk

Adverse event: NYHA class III or IV Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 76 affected / 1101 at risk

Adverse event: Nonfatal reinfarction
Serious: no
Organ System: Cardiac disorders
Frequency: 75 affected / 1101 at risk

Adverse event: Death from all causes
Serious: yes
Organ System: Cardiac disorders
Frequency: 153 affected / 1100 at risk

Adverse event: NYHA class III or IV Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 74 affected / 1100 at risk

Adverse event: Nonfatal reinfarction
Serious: no
Organ System: Cardiac disorders
Frequency: 61 affected / 1100 at risk
Study: NCT00004563

Adverse event: Leukopenia with pneumonia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Leukopenia with gastroenteritis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Pneumonia and Laryngospasm
Serious: yes
Organ System: Renal and urinary disorders
Notes: Complicating cystoscopy
Frequency: 3 affected / 79 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 79 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 79 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 79 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 79 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 79 at risk
Study: NCT00004980

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Transient headache and responsive to acetaminophen
Frequency: 16 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Transient headache and responsive to acetaminophen
Frequency: 3 affected / 23 at risk
Study: NCT00005047

Adverse event: Decreased WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 46 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 46 at risk

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

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