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| ID | Type | Description | Link |
|---|---|---|---|
| 30979754-JPN-MDS-101 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS).
This is an open-label (both physician and patient know the name and dosage of drug), multi-center study. This study consists of two parts, Phase I and Phase II. In Phase I, approximately 9 participants will be enrolled ie, 3 participants for dose level 1 (15 mg/m2 of JNJ-30979754) and 6 participants for dose level 2 (20 mg/m2 of JNJ-30979754). Once the tolerability of 20 mg/m2 is confirmed additional 30 participants will be included to receive 20 mg/m2 and approximate total participants in Phase II will be 36. This study will include screening period (within 14 days prior to the day of initial administration of Cycle 1) and dosing period (1 cycle consists of administration of study medication for first 5 consecutive days + rested for 23 days; ie, total 28 days). Cycles will be reapeated in participants in whom decitabine was expected to be effective. Safety evaluations will include assessment of adverse events, vital signs, body weight, clinical laboratory tests: hematology, blood biochemistry and urinalysis, cardiopulmonary function tests: ECG, chest X ray and oximeter analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: JNJ-30979754 15 mg/m2 | Experimental | JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 |
|
| Phase I: JNJ-30979754 20 mg/m2 | Experimental | JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 |
|
| Phase II: JNJ-30979754 20 mg/m2 | Experimental | JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-30979754 15 mg/m2 | Drug | JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000) | IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. | Up to 1 years after the last participant enrolled |
| Phase I and II: Number of Participants Who Experienced Adverse Events | Up to 1.5 years after the last participant enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax) | Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1 | |
| Phase I: Area Under the Plasma Concentration-time Curve (AUC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22816487 | Derived | Oki Y, Kondo Y, Yamamoto K, Ogura M, Kasai M, Kobayashi Y, Watanabe T, Uike N, Ohyashiki K, Okamoto S, Ohnishi K, Tomita A, Miyazaki Y, Tohyama K, Mukai HY, Hotta T, Tomonaga M. Phase I/II study of decitabine in patients with myelodysplastic syndrome: a multi-center study in Japan. Cancer Sci. 2012 Oct;103(10):1839-47. doi: 10.1111/j.1349-7006.2012.02386.x. Epub 2012 Sep 14. |
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9 participants were enrolled and treated in Phase 1. 36 participants (including 6 participants from Phase I) were enrolled in Phase II. 34 participants were treated and 2 participants were untreated in Phase II.
39 participants were enrolled at multiple sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: 15 mg/m2 | 15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1 |
| FG001 | Phase I and II: 20 mg/m2 | Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
For Baseline characteristics analysis, number of participants treated were analyzed (37) instead of number of participants enrolled (39). 2 enrolled participants were not treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: 15 mg/m2 | 15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1 |
| BG001 | Phase I and II: 20 mg/m2 |
| 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 | Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000) | IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. | Full Analysis Set (FAS): 34 participants were included in this analysis set for Phase II | Posted | Number | Participants | Up to 1 years after the last participant enrolled |
|
Up to 1.5 years after the last participant enrolled
Not provided
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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 | Phase I - 15 mg/m2 Group | 15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen Pharm KK Japan | +81-3-4411-5801 |
Not provided
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
Not provided
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|
| JNJ-30979754 20 mg/m2 | Drug | Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. Phase II: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles until the decitabine was expected to be effective in participants. |
|
|
Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last). |
| Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1 |
| Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000) | IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL. | Up to 28 Days of treatment Cycle 1 |
| Phase II: Median Time to Remission | Median time required for the participants to achieve remission (complete remission+partial remission). | Up to 1.5 years after the last participant enrolled |
| Phase II: Median Time to Improvement | Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement) | Up to 1.5 years after the last participant enrolled |
| Phase II: Median Duration of Remission | Median time duration for which participants achieved remission (complete remission+partial remission). | Up to 1.5 years after the last participant enrolled |
| Phase II: Median Duration of Overall Improvement | Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement). | Up to 1.5 years after the last participant enrolled |
| Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000) | IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL. | Up to 1.5 years after the last participant enrolled |
| Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial) | IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality. | Up to 1.5 years after the last participant enrolled |
| Hamamatsu |
| Japan |
| Hidaka | Japan |
| Nagasaki | Japan |
| Nagoya | Japan |
| Shinjuku | Japan |
| Tokyo | Japan |
| Specified organ function not met |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Other |
|
| Participants Not treated |
|
Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Phase I and II: Number of Participants Who Experienced Adverse Events | Safety Population: 9 participants in Phase I and 34 participants in Phase II were evaluated for safety | Posted | Number | Participants | Up to 1.5 years after the last participant enrolled |
|
|
|
| Secondary | Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax) | Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis | Posted | Mean | Standard Deviation | ng/mL | Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1 |
|
|
|
| Secondary | Phase I: Area Under the Plasma Concentration-time Curve (AUC) | Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last). | Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis | Posted | Mean | Standard Deviation | ng*h/mL | Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1 |
|
|
|
| Secondary | Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000) | IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL. | Full Analysis Set (FAS): 9 participants were included in this set for Phase I | Posted | Number | Participants | Up to 28 Days of treatment Cycle 1 |
|
|
|
| Secondary | Phase II: Median Time to Remission | Median time required for the participants to achieve remission (complete remission+partial remission). | 9 participants who achieved remission were evaluated. | Posted | Median | 95% Confidence Interval | Days | Up to 1.5 years after the last participant enrolled |
|
|
|
| Secondary | Phase II: Median Time to Improvement | Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement) | 14 participants who achieved overall improvement were evaluated. | Posted | Median | 95% Confidence Interval | Days | Up to 1.5 years after the last participant enrolled |
|
|
|
| Secondary | Phase II: Median Duration of Remission | Median time duration for which participants achieved remission (complete remission+partial remission). | 9 participants who achieved remission were evaluated. | Posted | Median | Full Range | Days | Up to 1.5 years after the last participant enrolled |
|
|
|
| Secondary | Phase II: Median Duration of Overall Improvement | Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement). | 14 participants who achieved overall improvement were evaluated. | Posted | Median | Full Range | Days | Up to 1.5 years after the last participant enrolled |
|
|
|
| Secondary | Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000) | IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL. | Full Analysis Set (FAS): 34 participants were included in this set | Posted | Number | Participants | Up to 1.5 years after the last participant enrolled |
|
|
|
| Secondary | Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial) | IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality. | 20 participants who had chromosomal abnormality were evaluated in Phase II for cytogenetic response. The IWG criteria requires 20 analyzable metaphases using conventional cytogenetic techniques. | Posted | Number | Participants | Up to 1.5 years after the last participant enrolled |
|
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase I - 20 mg/m2 Group | 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 | 1 | 6 | 6 | 6 |
| EG002 | Phase II: 20 mg/m2 | 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles | 11 | 34 | 34 | 34 |
| Sepsis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Pneumonia fungal | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Enterocolitis viral | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Aneamia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA Version 13.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | eye | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 13.1 | Systematic Assessment |
|
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Version 13.1 | 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 |
| AUC Infinity - Day 1 |
|
| AUC Infinity - Day 5 |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Not estimable |
|