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| ID | Type | Description | Link |
|---|---|---|---|
| DACOGENMYE-3002 | Other Identifier | Xian-Janssen Pharmaceutical Ltd |
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The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.
This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), open-label (all people involved in the study know the identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized (study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either 3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each patient in the study treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles. The entire study duration for each patient will be approximately two years. Safety will be evaluated for each patient by monitoring of adverse events, physical examinations, vital signs measurements, electrocardiogram, hematology and clinical chemistry testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-Day Dose schedule | Experimental | Decitabine will be administered at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3 hour period, repeated every 8 hours for 3 consecutive days. Cycles will be repeated every 6 weeks. |
|
| 5-Day Dose schedule | Experimental | Decitabine will be administered at a dose of 20 mg/m2 as a intravenous infusion within 1 hour, once daily for 5 consecutive days. Cycles will be repeated every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine at 15 mg/m2 | Drug | Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria | IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. | From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria | IWG 2006 response criteria - CR: bone marrow evaluation shows <= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of >= 1.5 g/dL, platelet increase of >= 30,000/mL (starting with > 20,000/mL), neutrophils increase of >= 100% and > 500/μL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26568466 | Derived | Wu D, Du X, Jin J, Xiao Z, Shen Z, Shao Z, Li X, Huang X, Liu T, Yu L, Li J, Chen B, He G, Cai Z, Liang H, Li J, Ruan C. Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study. Adv Ther. 2015 Nov;32(11):1140-59. doi: 10.1007/s12325-015-0263-8. Epub 2015 Nov 14. |
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This study was conducted across 12 centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3-Day Posology | Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks. |
| FG001 | 5-Day Posology | Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized analysis set included all randomized participants, regardless of whether having received any treatment, or whether having any post-baseline efficacy data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3-Day Posology | Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks. |
| BG001 | 5-Day Posology |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria | IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. | Intent-to-treat (ITT) population: Participants who received at least one dose of study medication. | Posted | Number | Participants | From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation |
|
From the date of informed consent signed until 30 days after last dose of study medication
Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3-Day Posology | Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell count decreased | Investigations | MedDRA version 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SR DIR COMPD DEV TM LDR | Janssen R&D US | 1 908 704-5197 |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Decitabine at 20 mg/m2 | Drug | Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle. |
|
| From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation |
| Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria | As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR). | From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation |
| Transfusion Independence: Number of Participants Who Were Transfusion Independent | A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more. | Baseline; up to 2 years |
| Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment) | Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration | Up to 2 years |
| Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment. | From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled |
| Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale | EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. | Baseline to end of treatment (approximately up to 2 years) |
| Chengdu |
| China |
| Guangdong | China |
| Hangzhou | China |
| Nanjing | China |
| Shanghai | China |
| Suzhou | China |
| Tianjin | China |
| Adverse Event |
|
| Poor Compliance |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Protocol Violation |
|
| Death |
|
| Other |
|
| Randomized but not treated. |
|
Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 5-Day Posology | Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks. |
|
|
|
| Secondary | Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria | IWG 2006 response criteria - CR: bone marrow evaluation shows <= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of >= 1.5 g/dL, platelet increase of >= 30,000/mL (starting with > 20,000/mL), neutrophils increase of >= 100% and > 500/μL. | Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. | Posted | Number | Participants | From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation |
|
|
|
| Secondary | Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria | As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR). | Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study. | Posted | Number | Percentage of Participants | From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation |
|
|
|
| Secondary | Transfusion Independence: Number of Participants Who Were Transfusion Independent | A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more. | Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point. | Posted | Number | Participants | Baseline; up to 2 years |
|
|
|
| Secondary | Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment) | Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration | Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Percentage of total days | Up to 2 years |
|
|
|
| Secondary | Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment. | Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled |
|
|
|
| Secondary | Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale | EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning. | Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to end of treatment (approximately up to 2 years) |
|
|
|
| 8 |
| 34 |
| 33 |
| 34 |
| EG001 | 5-Day Posology | Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks. | 26 | 98 | 97 | 98 |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA Version 14.1 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA Version 14.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 14.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA Version 14.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA Version 14.1 | Systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA Version 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 1.4 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Systematic Assessment |
|
| Oesophageal carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Malignant tumour excision | Surgical and medical procedures | MedDRA Version 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 14.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Anal infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Respiratory tract infection fungal | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Anal infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA version 14.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
|
Not provided
| CR (n=2, 3) |
|
| mCR (n=1, 10) |
|