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| ID | Type | Description | Link |
|---|---|---|---|
| DACOGENMDS2001 |
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The purpose of this study is to evaluate the response rate of decitabine in previously treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease associated with decreased production of blood cells, blood cells are produced but do not mature normally).
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or medical school team work on a medical research study), single-arm study of decitabine. The study will consist of 5 phases: Pre-treatment phase (before 30 days of first dose), Treatment phase (consist of 8 cycles, each cycle of 28 days), End-of-treatment phase (consist of 30-42 days after the last dose of cycle 8, or at time of discontinuation), Extension phase (1 cycle of 4 weeks) and Post-study phase or follow-up phase (every 2 months until 1 year, lost to follow-up or death). Participants who achieve a complete remission (when a medical problem gets better or goes away at least for a while) will be treated for at least 2 more cycles after first documentation of complete response (CR), after which treatment can be discontinued. Decitabine in a dose of 20 milligram per square meter (mg per m^2) will be administered intravenously over 1 hour infusion, 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. The primary objective is to evaluate the best response rate (complete response and partial response). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine | Experimental | Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | Decitabine 20 mg per m^2 will be administered intravenous infusion over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response | Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%. | Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hematologic Treatment Response | Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Taiwan, Ltd. Clinical Trial | Johnson & Johnson Taiwan Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua | Taiwan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Decitabine | Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Decitabine | Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. |
| 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 | Percentage of Participants With Response | Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%. | The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here 'N' specifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) |
|
Baseline up to 30 days after last medication
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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 | Decitabine | Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Medical Affairs, Janssen Taiwan | +886-2-23761255 |
Not provided
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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|
| Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) |
| Percentage of Participants With Cytogenetic Response | Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality. | Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) |
| Time to Acute Myeloid Leukemia (AML) Progression or Death | Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit. | Start of treatment until disease progression or death (whichever occur first) or up to 736 days |
| Overall Survival | Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact. | Start of treatment until disease progression or death (whichever occur first) or up to 736 days |
| Percentage of Participants With Transfusion Dependency | Transfusion requirements for both red blood cells as well as platelets were recorded for each participant. | 8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days |
| Percentage of Participants With Transfusion Independency | Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks. | 8 weeks before first dose and 736 days of treatment |
| Duration for Hospitalization | Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission. | Cycle 1 up to Cycle 8, each cycle of 28 days. |
| Number of Events Which Led to Hospitalization | The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported. | Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days |
| Quality of Life Assessment | The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life. | Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days) |
| Kaohsiung City |
| Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taipei | Taiwan |
| Tau-Yuan County 333 | Taiwan |
| Death |
|
| Adverse Event |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Decitabine | Decitabine 20 milligram per square meter (mg per m^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. |
|
|
| Secondary | Percentage of Participants With Hematologic Treatment Response | Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l. | Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluable for this outcome measure and 'n' specifies those participants who were evaluable for this outcome measure at given time point. | Posted | Number | Percentage of participants | Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) |
|
|
|
| Secondary | Percentage of Participants With Cytogenetic Response | Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality. | ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated at given time point. | Posted | Number | Percentage of participants | Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal) |
|
|
|
| Secondary | Time to Acute Myeloid Leukemia (AML) Progression or Death | Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit. | ITT population was defined as all participants who had received at least 1 dose of study medication. | Posted | Median | Full Range | Months | Start of treatment until disease progression or death (whichever occur first) or up to 736 days |
|
|
|
| Secondary | Overall Survival | Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact. | ITT population was defined as all participants who had received at least 1 dose of study medication. | Posted | Median | Full Range | Months | Start of treatment until disease progression or death (whichever occur first) or up to 736 days |
|
|
|
| Secondary | Percentage of Participants With Transfusion Dependency | Transfusion requirements for both red blood cells as well as platelets were recorded for each participant. | ITT population was defined as all participants who had received at least 1 dose of study medication. | Posted | Number | Percentage of participants | 8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days |
|
|
|
| Secondary | Percentage of Participants With Transfusion Independency | Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks. | ITT population was defined as all participants who had received at least 1 dose of study medication. | Posted | Number | percentage of participants | 8 weeks before first dose and 736 days of treatment |
|
|
|
| Secondary | Duration for Hospitalization | Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission. | ITT population was defined as all participants who had received at least one dose of treatment. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Mean | Standard Deviation | Days | Cycle 1 up to Cycle 8, each cycle of 28 days. |
|
|
|
| Secondary | Number of Events Which Led to Hospitalization | The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported. | ITT population was defined as all participants who had received at least 1 dose of study medication. | Posted | Number | Events | Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days |
|
|
|
| Secondary | Quality of Life Assessment | The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life. | ITT population was defined as all participants who had received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Unit on a scale | Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days) |
|
|
|
| 28 |
| 37 |
| 37 |
| 37 |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cardiac valve vegetation | Cardiac disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Induration | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Escherichia bacterial | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hepatic infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Splenic abscess | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Splenic infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| White blood cell disorder | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Platelet disorder | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hyperhidrosis | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Ulcer | General disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA version 11.1 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA version 11.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 11.1 | Non-systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA version 11.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 11.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Haemoglobin | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Basophil count increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Neutrophil count | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Urine output decrease | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA version 11.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Acute tonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Petechiae | Vascular disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA version 11.1 | Non-systematic Assessment |
|
Not provided
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| Title | Measurements |
|---|---|
|
| Cycle 2: HI-E |
|
| Cycle 2: HI-P |
|
| Cycle 2: HI-N |
|
| Cycle 3: HI-E |
|
| Cycle 3: HI-P |
|
| Cycle 3: HI-N |
|
| Cycle 4: HI-E |
|
| Cycle 4: HI-P |
|
| Cycle 4: HI-N |
|
| Cycle 5: HI-E |
|
| Cycle 5: HI-P |
|
| Cycle 5: HI-N |
|
| Cycle 6: HI-E |
|
| Cycle 6: HI-P |
|
| Cycle 6: HI-N |
|
| Cycle 7: HI-E |
|
| Cycle 7: HI-P |
|
| Cycle 7: HI-N |
|
| Cycle 8: HI-E |
|
| Cycle 8: HI-P |
|
| Cycle 8: HI-N |
|
| End of treatment: HI-E |
|
| End of treatment: HI-P |
|
| End of treatment: HI-N |
|
| Title | Measurements |
|---|---|
|
| Cycle 4, Partial Response (n=20) |
|
| Cycle 6, Complete Response (n=11) |
|
| Cycle 6, Partial Response (n=11) |
|
| Cycle 8, Complete Response (n=6) |
|
| Cycle 8, Partial Response (n=6) |
|
| End of treatment, Complete Response (n=17) |
|
| End of treatment, Partial Response (n=17) |
|
| Title | Measurements |
|---|---|
|
| Cycle 4 (n=28) |
|
| Cycle 5 (n=22) |
|
| Cycle 6 (n=21) |
|
| Cycle 7 (n=17) |
|
| Cycle 8 (n=16) |
|
| Title | Measurements |
|---|---|
|
| Allergic transfusion reaction |
|
| Dyspnoea with right pleural effusion |
|
| Febrile neutropenia |
|
| Fever |
|
| For Decitabine |
|
| MDS hematuria |
|
| Paronychia, pneumonia, heart failure |
|
| PAA,pancytopenia,fluctuated neutropenia fever |
|
| Right dorsal foot cellulitis |
|
| Rt Lw lung pneumonia with impending resp. failure |
|
| SAE+Schedule hospitalization for Decitabine |
|
| Septic shock |
|
| Not available |
|
| Title | Measurements |
|---|---|
|
| End of treatment, Q30 |
|