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The main purpose of this trial is to study whether the drug sitagliptin can be given safely to patients undergoing umbilical cord blood transplantation to speed up engraftment (recovery of blood counts after transplant).
Umbilical cord blood (UCB) is increasingly used as a source of stem cells for patients with blood cancers who need an allogeneic stem cell transplant (a transplant with stem cells from another person) but who have no suitably matched donors. The advantages of UCB are that (1) it is associated with less risk of transmitting an infection from a donor, (2) it can be more safely given even if not completely matched compared to bone marrow or blood stem cells, and (3) it is much more quickly available than unrelated donor bone marrow or blood stem cells. While more commonly used for transplantation in children, UCB is increasingly being used in adults. However, because they are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults, and engraftment can be delayed. This study is investigating whether the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation, overcoming the limitation of small stem cell doses associated with umbilical cord blood.
Sitagliptin is a drug given in tablet form that has been recently approved by the Food and Drug Administration (FDA) for the treatment of certain patients with diabetes mellitus (a disease that results in high blood sugar). Sitagliptin has been given to both normal healthy volunteers and diabetic patients and has been found to be safe and well-tolerated. The drug improves control of blood sugar in diabetics by inhibiting an enzyme called "CD26/DPP-IV." Recent studies at Indiana University (and other centers) have shown that this same enzyme plays an important role in the way transplanted stem cells find their way to the bone marrow and engraft. Transplant studies in mice have found that inhibiting CD26/DPP-IV significantly increases the engraftment of stem cells. Based on these studies, it is believed that drugs that inhibit CD26/DPP-IV, such as sitagliptin, may also increase engraftment in patients who receive clinical stem cell transplants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin once per day | Experimental | 600 mg sitagliptin once per day orally starting on Day -1 for a total of 4 doses |
|
| Sitagliptin twice per day | Experimental | 600 mg sitagliptin twice per day orally starting on Day -1 for a total of 8 doses |
|
| Sitagliptin three times per day | Experimental | 600 mg sitagliptin three times per day orally starting on Day -1 for a total of 12 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | 600 mg sitagliptin taken orally per the schedule listed in each of the three separate arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant | Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method. | Transplant (Day 0) through Day +30 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Engraftment | Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment. |
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Inclusion Criteria:
Patients must have one of the following disease types with disease-specific features as outlined in the protocol:
At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy
Patient age 18-55 years
Karnofsky Performance status ≥ 70%
No availability of a consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1.
No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1). Patients with unstable disease who are in danger of significant disease progression while waiting to procure volunteer donor cells will be eligible to be treated on this protocol, even if a matched donor is available.
Patients must have a matched or partially matched UCB unit with greater than 1.8 x10-7 nucleated cells/kg of recipient weight at the time of cryopreservation.
No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms).
No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
Non pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks.
Required baseline laboratory values as defined in the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherif Farag, MD, PhD | IU Simon Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23270493 | Derived | Farag SS, Srivastava S, Messina-Graham S, Schwartz J, Robertson MJ, Abonour R, Cornetta K, Wood L, Secrest A, Strother RM, Jones DR, Broxmeyer HE. In vivo DPP-4 inhibition to enhance engraftment of single-unit cord blood transplants in adults with hematological malignancies. Stem Cells Dev. 2013 Apr 1;22(7):1007-15. doi: 10.1089/scd.2012.0636. Epub 2013 Feb 15. |
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Initially based on single arm 2 stage design using 600 mg sitagliptin/24 hrs in RBC replete and RBC depleted UCB units. In an unplanned interim analysis after 1st 20 enrolled pts, protocol was amended to exclude RBC replete UCB units due to worse outcomes and to test more frequent dosing of sitagliptin due to suboptimal inhibition of plasma DPP-IV.
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| ID | Title | Description |
|---|---|---|
| FG000 | Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs | 600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients |
| FG001 | Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24 | 600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients |
| FG002 | 600 mg Sitagliptin/12 Hrs | 600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses |
| FG003 | 600 mg Sitagliptin/8 Hrs | 600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs | 600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients |
| BG001 | Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24 |
| 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 | Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant | Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method. | Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only | Posted | Number | 95% Confidence Interval | percentage of participants | Transplant (Day 0) through Day +30 |
|
up to 3 years
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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 | Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs | 600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients |
| 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 |
| 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherif Farag | IndianaU | 317-944-0920 | ssfarag@iu.edu |
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| 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 |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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 |
| Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity | Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater. | Transplant (Day 0) up to 3 years |
| Death |
|
| Engraftment failure |
|
| Veno-Occlusive Disease |
|
600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
| BG002 | 600 mg Sitagliptin/12 Hrs | 600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses |
| BG003 | 600 mg Sitagliptin/8 Hrs | 600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses |
| BG004 | 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 |
|
|
|
| Secondary | Time to Neutrophil Engraftment | Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment. | All patients enrolled and received treatment. | 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. | All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets. | Posted | Median | 95% Confidence Interval | days | Transplant (Day 0) up to 1 year |
|
|
|
| Secondary | Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity | Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater. | All patients enrolled and received treatment. | Posted | Number | participants | Transplant (Day 0) up to 3 years |
|
|
|
| 11 |
| 17 |
| 17 |
| 17 |
| EG001 | Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24 | 600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients | 6 | 7 | 7 | 7 |
| EG002 | 600 mg Sitagliptin/12 Hrs | 600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses | 2 | 4 | 4 | 4 |
| EG003 | 600 mg Sitagliptin/8 Hrs | 600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses | 1 | 1 | 1 | 1 |
| LYMPHATICS - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC ARRHYTHMIA - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC GENERAL - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RESTRICTIVE CARDIOMYOPATHY | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DIARRHEA | 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 |
|
| VOMITING | Gastrointestinal 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 |
|
| HYPOTHERMIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEPATOBILIARY/PANCREAS - OTHER | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LIVER DYSFUNCTION/FAILURE (CLINICAL) | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | 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 - BLOOD | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BRONCHUS | 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 UNKNOWN ANC - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - SINUS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| CERVICAL SPINE-RANGE OF MOTION | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONFUSION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) | 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 |
|
| EDEMA, LARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOXIA | 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 |
|
| HEMORRHAGE, GI - ABDOMEN NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GI - LOWER GI NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - URINARY NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VASCULAR - OTHER | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COAGULATION - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS) | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| LYMPHATICS - OTHER | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC ARRHYTHMIA - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC GENERAL - OTHER | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PERICARDIAL EFFUSION (NON-MALIGNANT) | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RESTRICTIVE CARDIOMYOPATHY | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL TACHYCARDIA/PAROXYSMAL ATRIAL TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VALVULAR HEART DISEASE | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| AUDITORY/EAR - OTHER | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - MIDDLE EAR | Ear and labyrinth disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| THYROID FUNCTION, LOW (HYPOTHYROIDISM) | Endocrine disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DRY EYE SYNDROME | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION) | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - EYE | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RETINAL DETACHMENT | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VISION-BLURRED VISION | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VISION-FLASHING LIGHTS/FLOATERS | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| WATERY EYE (EPIPHORA, TEARING) | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ASCITES (NON-MALIGNANT) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE) | 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 |
|
| DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DYSPHAGIA (DIFFICULTY SWALLOWING) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GASTRITIS (INCLUDING BILE REFLUX GASTRITIS) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GASTROINTESTINAL - OTHER | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHOIDS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HICCOUGHS (HICCUPS, SINGULTUS) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INCONTINENCE, ANAL | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ESOPHAGUS | 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) - ORAL CAVITY | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OBSTRUCTION, GI - STOMACH | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OCULAR/VISUAL - OTHER | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - ANUS | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - DENTAL/TEETH/PERIDONTAL | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - RECTUM | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: HEAD AND NECK | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: LIMB | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: TRUNK/GENITAL | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| EDEMA: VISCERA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | 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 - BUTTOCK | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - CHEST WALL | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - CHEST/THORAX NOS | 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 |
|
| SWEATING (DIAPHORESIS) | General 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 |
|
| LIVER DYSFUNCTION/FAILURE (CLINICAL) | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ALLERGY/IMMUNOLOGY - OTHER | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SERUM SICKNESS | Immune system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | 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 - ANAL/PERIANAL | 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 - COLON | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL | 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 - SMALL BOWEL NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS | 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 - COLON | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - CONJUNCTIVA | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - EYE NOS | 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 - MIDDLE EAR (OTITIS MEDIA) | 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 - SKIN (CELLULITIS) | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - SOFT TISSUE NOS | 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 |
|
| INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| WOUND COMPLICATION, NON-INFECTIOUS | 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 |
|
| BICARBONATE, SERUM-LOW | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| CARDIAC TROPONIN I (CTNI) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| CREATININE | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HAPTOGLOBIN | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMOGLOBIN | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| METABOLIC/LABORATORY - OTHER | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| PLATELETS | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| PROLONGED QTC INTERVAL | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| WEIGHT GAIN | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| WEIGHT LOSS | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BILIRUBIN (HYPERBILIRUBINEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CALCIUM, SERUM-LOW (HYPOCALCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| GLUCOSE, SERUM-LOW (HYPOGLYCEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| POTASSIUM, SERUM-HIGH (HYPERKALEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SODIUM, SERUM-HIGH (HYPERNATREMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SODIUM, SERUM-LOW (HYPONATREMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| TRIGLYCERIDE, SERUM-HIGH (HYPERTRIGLYCERIDEMIA) | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| FRACTURE | Musculoskeletal and connective tissue 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 |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - WHOLE BODY/GENERALIZED | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MUSCULOSKELETAL/SOFT TISSUE - OTHER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| OSTEOPOROSIS | 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 |
|
| PAIN - NECK | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SOFT TISSUE NECROSIS - EXTREMITY-LOWER | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CONFUSION | Nervous system 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 |
|
| MOOD ALTERATION - AGITATION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - ANXIETY | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| MOOD ALTERATION - DEPRESSION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROLOGY - OTHER | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| NEUROPATHY: MOTOR | 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 |
|
| PAIN - NEURALGIA/PERIPHERAL NERVE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SEIZURE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SYNCOPE (FAINTING) | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PSYCHOSIS (HALLUCINATIONS/DELUSIONS) | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BLADDER SPASMS | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| CYSTITIS | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| INCONTINENCE, URINARY | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - BLADDER | 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 |
|
| URINARY FREQUENCY/URGENCY | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| URINE COLOR CHANGE | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| IRREGULAR MENSES (CHANGE FROM BASELINE) | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - PELVIS | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - URETHRA | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - VAGINA | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VAGINAL DISCHARGE (NON-INFECTIOUS) | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VAGINAL DRYNESS | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - THROAT/PHARYNX/LARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| BRONCHOSPASM, WHEEZING | 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 |
|
| EDEMA, LARYNX | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HYPOXIA | 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 |
|
| PLEURAL EFFUSION (NON-MALIGNANT) | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PNEUMONITIS/PULMONARY INFILTRATES | 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 |
|
| VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) | 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 |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PAIN - SKIN | 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 |
|
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS) | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| RASH: HAND-FOOT SKIN REACTION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| SKIN BREAKDOWN/DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| ULCERATION | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, CNS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GI - ABDOMEN NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GI - ANUS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GI - LOWER GI NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GI - UPPER GI NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - BLADDER | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - URINARY NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, GU - VAGINA | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - BRONCHOPULMONARY NOS | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| HEMORRHAGE/BLEEDING - OTHER | Vascular 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 |
|
| PERIPHERAL ARTERIAL ISCHEMIA | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| PULMONARY HYPERTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| VASCULAR - OTHER | 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 |
| D008223 | Lymphoma |
| D011719 |
| Pyrazines |