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Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion.
Omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood consisting of mature myeloid and lymphoid cells as follows:
Omidubicel utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of hematopoietic progenitor cells (HPC) expanded in ex vivo cultures.
The overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omidubicel | Experimental | Received omidubicel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omidubicel | Biological | hematopoietic stem cell transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Transplant to Neutrophil Engraftment | Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive. The first day of the three measurements was designated the day of neutrophil engraftment. | by day 42 post-transplant inclusive |
| Cumulative Incidence of Neutrophil Engraftment | Death, second transplant, and relapse were competing risks at the time they occur if they occur prior to neutrophil engraftment, and no transplant was a competing risk at Day 0. If the patient failed to achieve neutrophil engraftment, they were considered to have a competing risk at Day 43. | by day 42 post-transplant inclusive |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Platelet Engraftment >20,000 Cells/uL | By Day 42 and Day 180 post-transplant | |
| Time to Platelet Engraftment >20,000 Cells/uL | Time to platelet engraftment >20,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 20,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated. The first day of the three measurements was designated the day of platelet engraftment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Horwitz, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Stanford University Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omidubicel | Received omidubicel |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omidubicel | Received omidubicel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | 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 | Time From Transplant to Neutrophil Engraftment | Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive. The first day of the three measurements was designated the day of neutrophil engraftment. | Analysis among engrafters | Posted | Median | Full Range | Days | by day 42 post-transplant inclusive |
|
|
Gd 2-3 infections and Non-serious common AEs: From conditioning until Day 42 post-transplant (average of 7.5 weeks) Gd 3-4 non serious common AEs: From transplant till 2 years post-transplant (average of 2 years) All grade non serious uncommon AEs: From transplant till Day 42 post-transplant (7.5 weeks) Life-threatening and fatal SAEs, or SARs : From consent till end of study (average of 2 years) All other SAEs: From conditioning till end of study (average of 2 years)
Adverse events graded per CTCAE v4.03 Infections graded per BMT-CTN grading
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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 | Omidubicel | Omidubicel is a cryopreserved stem/progenitor cell based product comprised of:
Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronit Simantov, MD | Gamida Cell | +16465310676 | ronit@gamida-cell.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2020 | Feb 23, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2025 | Feb 23, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| By Day 730 post-transplant |
| Cumulative Incidence of Platelet Engraftment >50,000 Cells/uL | By Day 42 and Day 180 post-transplant |
| Time to Platelet Engraftment >50,000 Cells/uL | Time to platelet engraftment >50,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 50,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated. The first day of the three measurements was designated the day of platelet engraftment. | By Day 730 post-transplant |
| Non-relapse Mortality | Non-relapse mortality was defined as any death not preceded by relapse. | By Day 180, Day 365 and Day 730 post-transplant |
| Overall Survival (OS) | OS probability was defined as the probability of participants remaining alive at specified time points following transplantation, estimated using Kaplan-Meier methods. | By Day 180, Day 365 and Day 730 post-transplant |
| Disease Free Survival (DFS) | Disease-free survival was defined as the survival without disease relapse or death from any cause, whichever came first. | By Day 365 and Day 730 post-transplant |
| Donor Chimerism | Patients considered to have donor chimerism when they had at least 95% donor chimerism | By day 100 and Day 730 post-transplant |
| Secondary Graft Failure (SGF) | By Day 730 post-transplant |
| Disease Relapse | By Day 365 and Day 730 post-transplant |
| Cumulative Incidence of Acute GvHD Grade II-IV | Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events. | By Day 100 post-transplant |
| Cumulative Incidence of aGvHD Grade III-IV | Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events. | By Day 100 post-transplant |
| Cumulative Incidence of Chronic GvHD | Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events. | By Day 180 and Day 730 post-transplant |
| Chronic GvHD-free Relapse-free Survival (cGRFS) | Chronic graft versus host disease-free, relapse-free survival (cGRFS) was defined as chronic GvHD, relapse, or death by any cause. | By Day 365 and Day 730 post-transplant |
| GvHD-free Relapse-free Survival (GRFS) | Graft versus host disease-free, relapse-free survival (GRFS) was defined as acute GvHD Grade III-IV, chronic GvHD, relapse, or death by any cause | By Day 365 and Day 730 post-transplant |
| Palo Alto |
| California |
| 94063 |
| United States |
| Loyola University, Cardinal Bernardin Cancer Center | Maywood | Illinois | 60153 | United States |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Not approved for transplant by site committee |
|
| Protocol logistics |
|
| Production failure |
|
| Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Primary diagnosis | Count of Participants | Participants |
|
| HLA match (/6) | Count of Participants | Participants |
|
| HLA match (/8) | Count of Participants | Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
|
| Primary | Cumulative Incidence of Neutrophil Engraftment | Death, second transplant, and relapse were competing risks at the time they occur if they occur prior to neutrophil engraftment, and no transplant was a competing risk at Day 0. If the patient failed to achieve neutrophil engraftment, they were considered to have a competing risk at Day 43. | Posted | Number | 95% Confidence Interval | Proportion of Participants | by day 42 post-transplant inclusive |
|
|
|
| Secondary | Cumulative Incidence of Platelet Engraftment >20,000 Cells/uL | Posted | Number | 95% Confidence Interval | Proportion of participants | By Day 42 and Day 180 post-transplant |
|
|
|
| Secondary | Time to Platelet Engraftment >20,000 Cells/uL | Time to platelet engraftment >20,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 20,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated. The first day of the three measurements was designated the day of platelet engraftment. | Posted | Median | Full Range | Days | By Day 730 post-transplant |
|
|
|
| Secondary | Cumulative Incidence of Platelet Engraftment >50,000 Cells/uL | Analysis among engrafters | Posted | Number | 95% Confidence Interval | Proportion of participants | By Day 42 and Day 180 post-transplant |
|
|
|
| Secondary | Time to Platelet Engraftment >50,000 Cells/uL | Time to platelet engraftment >50,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 50,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated. The first day of the three measurements was designated the day of platelet engraftment. | Posted | Median | Full Range | Days | By Day 730 post-transplant |
|
|
|
| Secondary | Non-relapse Mortality | Non-relapse mortality was defined as any death not preceded by relapse. | Posted | Number | 95% Confidence Interval | Proportion of participants | By Day 180, Day 365 and Day 730 post-transplant |
|
|
|
| Secondary | Overall Survival (OS) | OS probability was defined as the probability of participants remaining alive at specified time points following transplantation, estimated using Kaplan-Meier methods. | Posted | Number | 95% Confidence Interval | Proportion probability | By Day 180, Day 365 and Day 730 post-transplant |
|
|
|
| Secondary | Disease Free Survival (DFS) | Disease-free survival was defined as the survival without disease relapse or death from any cause, whichever came first. | Posted | Number | 95% Confidence Interval | Proportion probability | By Day 365 and Day 730 post-transplant |
|
|
|
| Secondary | Donor Chimerism | Patients considered to have donor chimerism when they had at least 95% donor chimerism | Posted | Number | Proportion Probability | By day 100 and Day 730 post-transplant |
|
|
|
| Secondary | Secondary Graft Failure (SGF) | Posted | Number | Proportion of Participants | By Day 730 post-transplant |
|
|
|
| Secondary | Disease Relapse | Posted | Number | 95% Confidence Interval | Proportion of Participants | By Day 365 and Day 730 post-transplant |
|
|
|
| Secondary | Cumulative Incidence of Acute GvHD Grade II-IV | Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events. | Posted | Number | 95% Confidence Interval | Proportion of Participants | By Day 100 post-transplant |
|
|
|
| Secondary | Cumulative Incidence of aGvHD Grade III-IV | Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events. | Posted | Number | 95% Confidence Interval | Proportion of Participants | By Day 100 post-transplant |
|
|
|
| Secondary | Cumulative Incidence of Chronic GvHD | Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events. | Posted | Number | 95% Confidence Interval | Proportion of Patients | By Day 180 and Day 730 post-transplant |
|
|
|
| Secondary | Chronic GvHD-free Relapse-free Survival (cGRFS) | Chronic graft versus host disease-free, relapse-free survival (cGRFS) was defined as chronic GvHD, relapse, or death by any cause. | Posted | Number | Proportion Probability | By Day 365 and Day 730 post-transplant |
|
|
|
| Secondary | GvHD-free Relapse-free Survival (GRFS) | Graft versus host disease-free, relapse-free survival (GRFS) was defined as acute GvHD Grade III-IV, chronic GvHD, relapse, or death by any cause | Posted | Number | Proportion Probability | By Day 365 and Day 730 post-transplant |
|
|
|
| 6 |
| 29 |
| 21 |
| 29 |
| 29 |
| 29 |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| BK virus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Bacteremia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Clostrodium difficile colitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Clostrodium Difficile infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Cytomegalovirus enteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Covid-19 pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Multiple organ disfunction syndrome | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
|
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Refractoriness to platelet transfusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypervolemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Acute lymphocytic leukemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
|
| Leukemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
|
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cystitis hemorrhagic | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Venoocclusive disease | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Edema | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypervolemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Blood sodium abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Venoocclusive disease | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
|
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|