Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142711 | Other Identifier | Japic |
Not provided
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To evaluate the tolerability and pharmacokinetics of SGI-110 when administered subcutaneously to Japanese patients with acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 | Experimental | SGI-110 36mg/m2 will be administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
|
| Cohort2 | Experimental | SGI-110 60mg/m2 will be administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
|
| Cohort3 | Experimental | SGI-110 90mg/m2 will be administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
|
| Cohort4 | Experimental | SGI-110 60mg/m2 will be administered subcutaneously once daily for 10 days (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGI-110 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT was defined as any of the following adverse events (AEs) occurring during Course 1 for which there was a reasonable probability or possibility of a causal relationship with the IMP. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
| 28 days (Day 1 to Day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) | |
| Time to Maximum Plasma Concentration (Tmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 |
Not provided
Inclusion Criteria:
Male or female patients with a diagnosis of AML (WHO classification 2008).
Patients with ECOG performance status (PS) of 0 to 2
Patients with adequate organ function
Women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at Screening). Women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with SGI-110 and for 3 months following last dosing.
Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (GVHD) and must be off immunosuppressive therapy by ≥2 weeks prior to IMP administration.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Junji Ikeda | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| kinki Region | Kyoto | Japan | ||||
| Kanto |
This trial consisted of a screening period, dose limiting toxicity (DLT) evaluation period (Course 1), and withdrawal examination. Subjects who completed investigational medicinal product (IMP) administration and all observations during the DLT evaluation period, and who did not have any apparent progression of AML, were permitted to be added extended treatment period (Course 2) to continue treatment with IMP following the DLT evaluation period if they wished.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| FG001 | Cohort 2 | SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| FG002 | Cohort 3 | SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28). |
| FG003 | Cohort 4 | SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Course 1 (DLT Evaluation Period) |
|
| ||||||||||||||||||
| Course ≥2 (Extended Treatment Period) |
|
Analysis population included subjects who had received at least one dose of the IMP.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| BG001 | Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Dose Limiting Toxicity (DLT) | DLT was defined as any of the following adverse events (AEs) occurring during Course 1 for which there was a reasonable probability or possibility of a causal relationship with the IMP. The severity of AEs was graded in accordance with Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
| DLT analysis population included subjects in whom tolerability had been assessed in Cohorts 1 to 4 (subjects who had received all doses and completed all assessments scheduled for the DLT evaluation period). | Posted | Number | participants | 28 days (Day 1 to Day 29) |
From the start of IMP administration up to 5 days after withdrawal
A treatment-emergent adverse event (TEAE) was defined as an AE occurring after the start of IMP administration.
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 | Cohort 1 | SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2017 | Feb 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2018 | Feb 11, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C580831 | guadecitabine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
| Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
| Terminal-phase Elimination Half-life (T1/2,z) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
| Region |
| Japan |
| Kyusyu | Region | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28).
| BG002 | Cohort 3 | SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28). |
| BG003 | Cohort 4 | SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Cohort 1 | SGI-110 36mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| OG001 | Cohort 2 | SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
| OG002 | Cohort 3 | SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28). |
| OG003 | Cohort 4 | SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Analysis population included subjects whose plasma drug concentrations had been measured. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Analysis population included subjects whose plasma drug concentrations had been measured. | Posted | Median | Full Range | h | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Analysis population included subjects whose plasma drug concentrations had been measured. | Posted | Mean | Standard Deviation | ng·h/mL | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
|
|
|
| Secondary | Terminal-phase Elimination Half-life (T1/2,z) of SGI-110 and Its Active Metabolite Decitabine Following Single and Multiple Administration of SGI-110 | Analysis population included subjects whose plasma drug concentrations had been measured. | Posted | Mean | Standard Deviation | h | Pre-dose, 15min, 30min, 60min, 90min, 2h, 3h, 4h, 6h, 8h, 24h after dosing (Cohorts 1, 2, and 4: Day 1 and Day 5, Cohort 3: Day 1 and Day 12) |
|
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | Cohort 2 | SGI-110 60mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). | 0 | 6 | 5 | 6 | 6 | 6 |
| EG002 | Cohort 3 | SGI-110 60mg/m2 was administered subcutaneously once daily for 10 days in total (Day 1 to Day 5 and Day 8 to Day 12 with dosing, Day 6 and 7 with non-dosing), followed by a 16-day non-dosing period (Day 13 to Day 28). | 0 | 7 | 4 | 7 | 7 | 7 |
| EG003 | Cohort 4 | SGI-110 90mg/m2 was administered subcutaneously once daily for 5 consecutive days (Day 1 to Day 5), followed by a 23-day non-dosing period (Day 6 to Day 28). | 0 | 4 | 1 | 4 | 4 | 4 |
| Cellulitis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Diabetes insipidus | Endocrine disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Trichophytosis | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Iron overload | Metabolism and nutrition disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Sleep disorder due to a general medical condition | Psychiatric disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Trichiasis | Eye disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Internal haemorrhage | Vascular disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Oral mucosa erosion | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Senile pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Genital erosion | Reproductive system and breast disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Genital ulceration | Reproductive system and breast disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Injection site vesicles | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Reticulocyte count decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Antithrombin III decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Prothrombin level decreased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
|
| decitabine |
|
|
|
| decitabine |
|
|
|
| decitabine |
|
|
|
| decitabine |
|
|