Not provided
Not provided
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Slow accrual
Not provided
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The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; |
|
| 2 | Experimental | Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Body Irradiation | Radiation | 8 Gy on Day -9 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation | To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented. | thru 6 months after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Regimen-related Toxicity | The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen. | Up to 1 year |
| Time to Neutrophil Engraftment |
Not provided
Inclusion Criteria:
Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria
Acute lymphoblastic leukemia (ALL) with one of the following criteria
Myelodysplasia, RAEB I
Donor has been identified
Age ≤ 65 years.
Performance Status 0-1.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sherif Farag, MD/PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
Not provided
This protocol had 9 enrolled patients, but one patient never received a transplant nor was randomized. There had been no efficacy or safety data entered for this patient, and they are excluded from the results.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Without Paliferim | Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 |
| FG001 | Treatment With Palifermin | Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Without Paliferim | Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 |
| BG001 | Treatment With Palifermin |
| 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 | Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation | To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented. | Patients who received a transplant | Posted | Number | 95% Confidence Interval | percentage of patients | thru 6 months after transplant |
|
Up to 1 year
Not provided
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 | Treatment Without Paliferim | Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG; Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PAIN - OTHER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLOOD/BONE MARROW - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherif Farag | IndianaU | 317-278-0460 | ssfarag@iu.edu |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014916 | Whole-Body Irradiation |
| D013852 | Thiotepa |
| C024352 | fludarabine |
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D063088 | Phosphoramides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Thiotepa |
| Drug |
5 mg/kg/d on Day -8 to -7 |
|
| Fludarabine | Drug | 40 mg/m2/d on Day -6 to -3 |
|
| Rabbit ATG | Biological | 2.5 mg/kg/d on Day -5 to -2 |
|
|
| Palifermin | Drug | 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2 |
|
|
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.
| Transplant (Day 0) up to 1 year |
| Time to Platelet Engraftment | Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided. | Transplant (Day 0) up to 1 year |
| Acute Graft vs. Host Disease (GvHD) | Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study. | Up to 1 year |
| Chronic Graft vs. Host Disease (GvHD) | Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study. | Up to 1 year |
| Frequency of Infection | Number of unique patients with bacterial and/or viral infections reported. | Day 0 through 1 year post transplantation |
| Withdrawal by Subject |
|
| Disease Progression |
|
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Treatment With Palifermin |
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2 |
|
|
| Secondary | Regimen-related Toxicity | The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen. | Patients who received a transplant | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Secondary | Time to Neutrophil Engraftment | Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided. | Patients who received a transplant | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
|
|
| Secondary | Time to Platelet Engraftment | Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided. | Patients who received a transplant and who achieved platelet recovery/engraftment of platelets | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
|
|
| Secondary | Acute Graft vs. Host Disease (GvHD) | Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study. | Patients who received a transplant | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Secondary | Chronic Graft vs. Host Disease (GvHD) | Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study. | Patients who received a transplant | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Secondary | Frequency of Infection | Number of unique patients with bacterial and/or viral infections reported. | Patients who received a transplant | Posted | Count of Participants | Participants | Day 0 through 1 year post transplantation |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Treatment With Palifermin | Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG Total Body Irradiation: 8 Gy on Day -9 Thiotepa: 5 mg/kg/d on Day -8 to -7 Fludarabine: 40 mg/m2/d on Day -6 to -3 Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2 Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2 | 1 | 5 | 5 | 5 |
| INFECTION - OTHER | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| COAGULATION - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LYMPHATICS - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| THROMBOTIC MICROANGIOPATHY (E.G., THROMBOTIC THROMBOCYTOPENIC PURPURA [TTP] OR HEMOLYTIC UREMIC SYND | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC GENERAL - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LEFT VENTRICULAR DIASTOLIC DYSFUNCTION | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PERICARDIAL EFFUSION (NON-MALIGNANT) | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OCULAR/VISUAL - OTHER | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VISION-BLURRED VISION | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ASCITES (NON-MALIGNANT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DISTENSION/BLOATING, ABDOMINAL | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - LARGE BOWEL | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - ORAL CAVITY | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - RECTUM | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS - OTHER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: LIMB | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - OTHER | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - PAIN NOS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RIGORS/CHILLS | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BILIRUBIN (HYPERBILIRUBINEMIA) | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEPATOBILIARY/PANCREAS - OTHER | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION - OTHER | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - VAGINA | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - BLADDER (URINARY) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - BLOOD | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - CATHETER-RELATED | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - COLON | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - LIP/PERIORAL | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - SINUS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| ALKALINE PHOSPHATASE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| CREATININE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BACK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BONE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - JOINT | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - MUSCLE | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ENCEPHALOPATHY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY: SENSORY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONFUSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MENTAL STATUS | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - DEPRESSION | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - BLADDER | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - URINARY NOS | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL/GENITOURINARY - OTHER | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - VAGINA | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| IRREGULAR MENSES (CHANGE FROM BASELINE) | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - PERINEUM | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - PHARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NASAL CAVITY/PARANASAL SINUS REACTIONS | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - THROAT/PHARYNX/LARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PLEURAL EFFUSION (NON-MALIGNANT) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY - OTHER | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DERMATOLOGY/SKIN - OTHER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009943 |
| Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |