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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7365-240 |
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The primary objective of this study is to evaluate the safety, tolerability, and efficacy of temozolomide in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) participants who are not candidates for standard induction therapy and exhibit low MGMT expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide | Experimental | Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at the End of Temozolomide Induction | Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts. | at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide | Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. | Up to 1 year after treatment ends (up to 115 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17252015 | Result | Brandwein JM, Yang L, Schimmer AD, Schuh AC, Gupta V, Wells RA, Alibhai SM, Xu W, Minden MD. A phase II study of temozolomide therapy for poor-risk patients aged >or=60 years with acute myeloid leukemia: low levels of MGMT predict for response. Leukemia. 2007 Apr;21(4):821-4. doi: 10.1038/sj.leu.2404545. Epub 2007 Jan 25. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide | Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide | Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. | Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)] |
| Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide | OS was defined as the time from start of treatment until death or end of study. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. | Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)] |
| Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression | Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers. | Baseline |
| MGMT Expression in Leukemic Blasts at the Time of Relapse | Low MGMT expression was defined as MGMT/β-actin ratio of <0.2. MGMT & β-actin are cancer biomarkers. | Up to 1 year after treatment ends (up to 115 weeks) |
| Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity | Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions. | From first dose to 30 days after last dose of study drug (up to 67 weeks) |
| Progression-free Survival for Participants Achieving PR, MLSF, or MR | Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts. | Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)] |
| Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30 | The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL. | Baseline and post-study visit (63 weeks) |
| Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13 | The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms. | Baseline and post-study visit (63 weeks) |
| Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G | The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social & emotional well being, whether a high score or a lower one indicated a better outcome depended on the question. | Baseline and post-study visit (63 weeks) |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide | Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number of participants who received treatment | Mean | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | Number of participants who received treatment | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number of participants who received treatment | Number | participants |
|
| 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 | Clinical Response at the End of Temozolomide Induction | Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts. | Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) | Posted | Number | participants | at the end of each cycle (approximately 4 weeks post start of cycle), up to a maximum 63 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response in Participants Achieving Complete Response (CR) and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide | Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. | Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) | Posted | Median | Full Range | Days | Up to 1 year after treatment ends (up to 115 weeks) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Relapse-free Survival in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide | Relapse-free survival was defined as time to disease progression. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. | Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) | Posted | Median | 95% Confidence Interval | months | Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)] |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Participants Achieving CR or CRp and Proceeding to Reduced Dose-intensity Maintenance Therapy With Temozolomide | OS was defined as the time from start of treatment until death or end of study. Complete Response (CR): < 5% blasts in normocellular bone marrow (BM); Absolute Neutrophil Count (ANC) > 1.0 x 10^9/L, platelets > 100 x 10^9/L, and no extramedullary disease. CR with incomplete platelet recovery (CRp): All the criteria of CR but with platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. | Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) | Posted | Median | 95% Confidence Interval | months | Start of treatment until death or end of study [up to 1 year after treatment ends (up to 115 weeks)] |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Previously Untreated Participants With Low O6-Methylguanine Methyltransferase (MGMT) Expression | Low MGMT expression was defined as MGMT/β-actin ratio < 0.2. MGMT & β-actin are cancer biomarkers. | All screened participants | Posted | Number | participants | Baseline |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | MGMT Expression in Leukemic Blasts at the Time of Relapse | Low MGMT expression was defined as MGMT/β-actin ratio of <0.2. MGMT & β-actin are cancer biomarkers. | Analysis could not be performed due to lack of specimens. | Posted | Up to 1 year after treatment ends (up to 115 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CR, PR, or MLFS Who Received Modified Low Dose Maintenance Therapy (100 mg/m^2/Day x21 Days of Each 28 Day Cycle) and Experienced Toxicity | Toxicity was defined as any adverse event experienced by a participant regardless of causal relationship with study treatment. An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment. Adverse events may have included the onset of new illness and/or the exacerbation of preexisting conditions. | Number of participants who achieved CR, PR, or MLFS and received modified low dose maintenance therapy | Posted | Number | participants | From first dose to 30 days after last dose of study drug (up to 67 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival for Participants Achieving PR, MLSF, or MR | Progression-free survival was defined as time to disease progression. Morphologic leukemia-free state (MLFS): complete clearance of blasts from marrow and blood, but criteria for CR or CRp not met. Partial response (PR): decrease ≥ 50% BM blasts. Minimal Response (MR): decrease ≥ 25% but <50% BM blasts. | Efficacy evaluable population (all eligible participants who completed at least one additional disease evaluation after baseline) who achieved PR, MLSF, or MR | Posted | Median | 95% Confidence Interval | months | Start of treatment until disease progression [up to 1 year after treatment ends (up to 115 weeks)] |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30 | The EORTC QLQ-C30 was a 30-item questionnaire developed to assess the QoL of cancer patients. Scores ranged from 0 -100. For functional and global QoL scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL. | Analysis could not be performed due to incomplete data. | Posted | Baseline and post-study visit (63 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by EORTC QLQ-LC13 | The EORTC QLQ-LC13 was a 13-item questionnaire developed to supplement the EORTC QLQ-C30 in lung cancer patients. It had a score range 0-100 with higher scores representing an increase in symptoms. | Analysis could not be performed due to incomplete data. | Posted | Baseline and post-study visit (63 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life (QoL) in Participants Receiving Long Term Temozolomide Therapy Assessed by Functional Assessment of Cancer Therapy (FACT)-G | The FACT-G was a 27-item questionnaire developed to assess the QoL in patients with chronic illnesses. Scores ranged from 0 to 28. For physical well being, lower scores indicated a better outcome. For functional well being, higher scores indicated a better outcome. For social & emotional well being, whether a high score or a lower one indicated a better outcome depended on the question. | Analysis could not be performed due to incomplete data. | Posted | Baseline and post-study visit (63 weeks) |
|
|
Not provided
Population was all treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEMOZOLOMIDE | Temozolomide capsules orally, once daily: 1 induction cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), 1 consolidation cycle (200 mg/m^2/day for 7 days in 1 28 day cycle), then 200 mg/m^2/day for 7 days each 28-day cycle or for 5 days each 28-day cycle (12 cycle maximum). Alternatively participants could have received 100 mg/m^2/day for 21 days of each 28-day cycle (12 cycle maximum). | 25 | 47 | 45 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NEUTROPHILIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| COLONIC STENOSIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| FUNGAL INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| GASTROINTESTINAL FUNGAL INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PYOMYOSITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| SUBDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| TUMOUR LYSIS SYNDROME | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PNEUMONIA FUNGAL | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MOUTH HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| PETECHIAE | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
The Study Chair agrees not to publish/present any interim results without the Sponsor's prior written consent. The Principal Investigators (PIs) agree to provide 30 days prior to submission to the Sponsor to review copies of abstracts/manuscripts. The Sponsor shall have proper representation on publications and editorial rights with regard to data analysis, presentation, proprietary information, and accuracy. If the parties disagree, the PIs agree to meet with the Sponsor to discuss/resolve.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|
|
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