Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Acute Myeloid Leukemia With Multilineage Dysplasia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm
Conditions
Brief summary
This phase II trial studies the effect of adding pomalidomide to usual chemotherapy treatment (daunorubicin and cytarabine liposome) in treating patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes. Pomalidomide may stop the growth of blood vessels, stimulate the immune system, and kill cancer cells. Chemotherapy drugs, such as daunorubicin and cytarabine liposome, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding pomalidomide to chemotherapy treatment with daunorubicin and cytarabine liposome may be effective in improving some treatment outcomes in patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes.
Detailed description
PRIMARY OBJECTIVES: I. To establish recommended phase 2 dose (RP2D) of pomalidomide after liposome-encapsulated daunorubicin-cytarabine (daunorubicin and cytarabine liposome) induction. II. To compare the rate of overall complete response (CR)/complete response with incomplete hematologic recovery (CRi) with daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed acute myeloid leukemia (AML) with preexisting myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myeloproliferative neoplasm (MPN); therapy-related AML (t-AML); or AML with myelodysplasia-related changes (MRC) based on cytogenetics or morphologic dysplasia. SECONDARY OBJECTIVES: I. To evaluate and compare rates of CR (full hematologic recovery) between daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML or AML with MRC. II. To evaluate and compare toxicities (including treatment-related mortality) of daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. III. To detect and compare the presence of minimal residual disease (MRD) by flow cytometry in those who achieve CR/CRi with daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. IV. To compare median event-free survival (EFS) of daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. V. To compare median overall survival (OS) of daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. VI. To compare median and 2-year disease-free survival (DFS) after CR/CRi with daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. VII. To compare rates of allogeneic stem cell transplant (SCT) after daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. EXPLORATORY OBJECTIVES: I. To assess for molecular biomarkers, Aiolos expression, and immune correlates of response with daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. II. To assess for differences in MRD by molecular based platforms in daunorubicin and cytarabine liposome + pomalidomide versus daunorubicin and cytarabine liposome alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 and then pomalidomide orally (PO) once daily (QD) beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. ARM B: INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. After completion of study treatment, patients are followed up for 30 days, then up to 5 years after the start of induction therapy or until death, whichever occurs first.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
PROCEDUREBone Marrow Aspiration and Biopsy
Undergo bone marrow aspirate and biopsy
DRUGLiposome-encapsulated Daunorubicin-Cytarabine
Given IV
DRUGPomalidomide
Given PO
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathological confirmation of AML as defined by histologic, morphologic, or cytological evidence/confirmation of \>= 20% blasts in bone marrow aspirate and/or biopsy * Must meet criteria for t-AML or AML with MRC as defined by the 5th Edition of the World Health Organization (WHO) Classification of Myeloid Neoplasms or the International Consensus Classification (ICC) of Myeloid Neoplasms. Patients must meet one of the following criteria: * Therapy-related AML (AML derived from prior chemotherapy or radiation therapy) * AML originating from prior hematologic malignancy (MDS, CMML, or MPN) * AML with myelodysplasia-related cytogenetic abnormalities: * One of the following cytogenetic abnormalities: * Complex karyotype (3 or more unrelated chromosomal abnormalities in the absence of other class-defining recurrent genetic abnormalities as defined by WHO or ICC) * -7/del(7q) * Del(5q)/t(5q)/add(5q) * +8 * i(17q) * -17/add(17p) or del(17p) * Del(20q) * -13/del(13q) * Del(11q) * Del(12p)/t(12p)/add(12p) * idicX(q13) * AML with myelodysplasia-related mutations: Must have a mutation in one of the following genes: * ASXL1 * BCOR * EZH2 * RUNX1 * SF3B1 * SRSF2 * STAG2 * U2AF1 * ZRSR2 * No prior treatment for AML other than cytoreductive doses of hydroxyurea or leukapheresis * Age \>= 18 and =\< 75 years on day of signing informed consent are eligible who are planned for intensive chemotherapy. Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with daunorubicin and cytarabine liposome in patients \< 18 years of age, children are excluded from this study. Patients \> 75 years are not candidates for intensive chemotherapy with daunorubicin and cytarabine liposome * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky \>= 60%) * Total bilirubin =\< 1.5 institutional upper limit of normal (ULN) unless due to leukemic infiltration, Gilbert's Syndrome, or hemolysis * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN * Creatinine \>= 30 ml/min creatinine clearance by Cockcroft-gault * Left ventricular ejection fraction (LVEF) \>= 50% * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured with undetectable HCV viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Females of childbearing potential (FCBP), defined as a female who: 1) has reached menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) must have a negative pregnancy test 72 hours prior to the start of study therapy. For FCBPs in Arm A, they must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion criteria
* Patients with Wilson's Disease or Copper-related metabolic disorders * Absolute blast count \> 30 x 10\^9/L (cytoreduction with leukapheresis or hydroxyurea can be used to achieve absolute blast count \< 30 x 10\^9/L prior to day 1 of treatment) * Cumulative daunorubicin lifetime exposure \> 330 mg/m\^2 and \> 180 mg/m\^2 with prior mediastinal radiation therapy * Patients with known active central nervous system leukemia should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients receiving intrathecal chemotherapy prophylaxis should receive pomalidomide \>= 3 days after administration * Patients with uncontrolled intercurrent illness including, but not limited to, active and uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia. Patients with infection under active treatment and controlled with antibiotics are eligible * Known additional malignancy (with the exception of prior hematologic malignancies that have transformed to AML) that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer or patients receiving maintenance treatments without active disease (for example, hormonal therapy for breast cancer or prostate cancer or other adjuvant chemotherapy approaches). Anti-cancer therapy as above should be discontinued \> 72 hours prior to day 1 of treatment * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Receipt of prior allogeneic stem cell transplant * Administration of any therapy for MDS, CMML, or MPN (conventional or unconventional) must be completed by 2 weeks prior to treatment with daunorubicin and cytarabine liposome. Use of strong CYP1A2 inhibitors should be avoided * Patients who are receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide (e.g. lenalidomide, thalidomide) or daunorubicin and cytarabine liposome or their excipients * Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide, or similar drugs in the past * Pregnant women are excluded from this study because pomalidomide is an immunomodulatory agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding should be discontinued if the mother is treated with pomalidomide. These potential risks may also apply to other agents used in this study. Women of childbearing potential must be willing to undergo pregnancy testing * Any other medical condition that in the opinion of investigator would place patient at increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent or serious thromboembolic events such as massive pulmonary embolism)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi) | Up to 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR With Full Hematologic Recovery (Absolute Neutrophil Count > 1 x 10^9/L and Platelets > 100 x 10^9/L) | Up to 5 years | Will be assessed and compared with both arms A and B. |
| Incidence of Adverse Events | Up to 30 days after last dose, up to 2 years | Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 and compared descriptively between Arms A and B. Serious adverse events are denoted by "\[SAE\]". |
| Complete Response (CR) Without Minimal Residual Disease (MRD) | Up to 5 years | Will assess CR without MRD by flow cytometry via Hematologics, Inc. compare descriptively between Arms A and B. |
| Event-free Survival | From day 1 of liposome-encapsulated daunorubicin-cytarabine until no response is achieved, relapse or death, will be assessed for up to 5 years | Will be compared between Arms A and B. |
| Disease-free Survival (DFS) | From CR/CRi until relapse or death, assessed at 2 years | Will be compared between Arms A and B. |
| Disease-free Survival | From CR/CRi until relapse or death, assessed up to 5 years | Will be compared between Arms A and B. |
| Overall Survival (OS) | From randomization until death or last follow-up, assessed up to 5 years | Will be compared between Arms A and B. |
| Rate of Allogeneic Stem Cell Transplantation | Up to 5 years | Will be compared between Arms A and B. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoshua F Zeidner
Ohio State University Comprehensive Cancer Center LAO
Participant flow
Pre-assignment details
One participant who was consented to the study declined to participate before being randomized to an arm.
Participants by arm
| Arm | Count |
|---|---|
| Safety Run In DL1 (14 Days Pomalidomide) Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.
Biospecimen Collection: Undergo collection of blood samples
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Pomalidomide: Given PO | 6 |
| Safety Run In DL-1 (10 Days Pomalidomide) Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 10 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.
Biospecimen Collection: Undergo collection of blood samples
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Pomalidomide: Given PO | 3 |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.
Biospecimen Collection: Undergo collection of blood samples
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
Pomalidomide: Given PO | 16 |
| Arm B (Daunorubicin and Cytarabine Liposome) INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.
Biospecimen Collection: Undergo collection of blood samples
Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV | 18 |
| Total | 43 |
Baseline characteristics
| Characteristic | Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Safety Run In DL-1 (10 Days Pomalidomide) | Safety Run In DL1 (14 Days Pomalidomide) | Total | Arm B (Daunorubicin and Cytarabine Liposome) |
|---|---|---|---|---|---|
| Age, Continuous | 63 years | 66 years | 68.5 years | 63 years | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 3 Participants | 6 Participants | 42 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 3 Participants | 5 Participants | 35 Participants | 15 Participants |
| Region of Enrollment United States | 16 participants | 3 participants | 6 participants | 43 participants | 18 participants |
| Sex: Female, Male Female | 9 Participants | 2 Participants | 5 Participants | 26 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 1 Participants | 1 Participants | 17 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 7 | 2 / 3 | 11 / 20 | 7 / 19 |
| other Total, other adverse events | 7 / 7 | 3 / 3 | 20 / 20 | 18 / 19 |
| serious Total, serious adverse events | 7 / 7 | 3 / 3 | 19 / 20 | 19 / 19 |
Outcome results
Primary
Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)
Time frame: Up to 2 years
Population: This outcome measure was not reported on for the safety run-in phase
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi) | 9 Participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi) | 13 Participants |
Secondary
Complete Response (CR) Without Minimal Residual Disease (MRD)
Will assess CR without MRD by flow cytometry via Hematologics, Inc. compare descriptively between Arms A and B.
Time frame: Up to 5 years
Secondary
CR With Full Hematologic Recovery (Absolute Neutrophil Count > 1 x 10^9/L and Platelets > 100 x 10^9/L)
Will be assessed and compared with both arms A and B.
Time frame: Up to 5 years
Secondary
Disease-free Survival
Will be compared between Arms A and B.
Time frame: From CR/CRi until relapse or death, assessed up to 5 years
Secondary
Disease-free Survival (DFS)
Will be compared between Arms A and B.
Time frame: From CR/CRi until relapse or death, assessed at 2 years
Population: This outcome measure was not reported on for the safety run-in phase
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Disease-free Survival (DFS) | 8.18 months |
| Arm B (Daunorubicin and Cytarabine Liposome) | Disease-free Survival (DFS) | NA months |
Secondary
Event-free Survival
Will be compared between Arms A and B.
Time frame: From day 1 of liposome-encapsulated daunorubicin-cytarabine until no response is achieved, relapse or death, will be assessed for up to 5 years
Secondary
Incidence of Adverse Events
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 and compared descriptively between Arms A and B. Serious adverse events are denoted by \[SAE\].
Time frame: Up to 30 days after last dose, up to 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Left lateral orbital wall fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Delirium | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pulmonary Hypertension | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - L nasal dorsum laceration | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep) | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Delusions | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Sinusitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RLE DVT | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Infusion Related Reaction | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Depression | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Eosinophilia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Sepsis | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Sars-COV-2 | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Diarrhea | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] EKG QT corrected interval prolong | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Pediculosis captis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | International Normalized Ratio (INR) Increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dizziness | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal dryness | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypoxia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypotension | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dry Mouth | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Wet Purpura | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypophosphatemia | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hyponatremia | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dysgeusia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Dyspnea | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypokalemia | 6 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypocalcemia | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dyspnea | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal irritation | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypoalbuminemia | 7 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hyperuricemia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | EKG QT Corrected Interval Prolong | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] White Blood Cell Decreased | 6 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypertension | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hyperphosphatemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Ear and Labyrinth - Other - Serous otitis media | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Disease Progression | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypernatremia | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypermagnesemia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hyperkalemia | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Edema Face | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Delirium | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Creatinine Incrased | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hyperhidrosis | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hyperglycemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Elevated Lactate Dehydrogenase (LDH) | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Catheter Related Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypercalcemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hemorrhoids | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Eosinophilia | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Sepsis | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hemorrhoidal Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hematuria | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Epistaxis | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Blood Bilirubin Increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hematoma | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Heart Failure | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Esophageal Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Atrial Flutter | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hearing Impaired | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Extrapyramidal Disorder | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg subcu nodules | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Headache | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Generalized Muscle Weakness | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Fall | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Seizure | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Generalized Edema | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Gastroesophageal reflux disease | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Fatigue | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Atrial Fibrillation | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - hematochezia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Rectal bleeding | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Febrile Neutropenia | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Respiratory Failure | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Melena | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Lower GI hemmorrage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Fever | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Anxiety | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Lip lesion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Gum Bleeding | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Fibrinogen Decreased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Anorexia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Genitourinary bleeding | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Diverticulitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Bright red blood per rectum | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Floaters | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Anemia | 7 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Black lesion on tongue | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Gamma-Glutamyl Transferase (GGT) Increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Flushing | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Alkaline phosphatase increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Folliculitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Cardiac Arrest | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Gastrointestinal Pain | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Acute Kidney Injury | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Activated Partial Thromboplastin Time (PTT) Prolonged | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Upper Gastrointestinal Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Abdominal Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Aspartate Aminotransferase (AST) Increased | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypotension | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Renal Calculi | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Acute Respiratory Distress Syndrome (ARDS) | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Infections & infestations - Other - Sepsis | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Rectal Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Alanine Aminotransferase (ALT) Increased | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Genital Edema | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | White Blood Cell Decreased | 5 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Wheezing | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Nausea | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Ear Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Weight Loss | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Sinus Bradycardia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Rash Maculo-papular | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Weight Gain | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Vomiting | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Supraventricular Tachycardia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Pulmonary Edema | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Ventricular Arrhythmia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Platelet Count Decreased | 7 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Vascular Access Complication | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Vaginal Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Vascular Access Complication | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hoarseness | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Vaginal Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Urinary Urgency | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Vomiting | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Urinary Retention | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Urinary Retention | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Urinary Incontinence | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Neutrophil Count Decreased | 7 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Urinary Frequency | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Upper Respiratory Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Alopecia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Lymphocyte Count Increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Lymphocyte Count Decreased | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Upper Gastrointestinal Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Typhlitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Bruising | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Lung Infection | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Hypomagnesemia | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Tremor | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Gastrointestinal bleeding | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Thrush | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Thromboembolic Event | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Supraventricular Tachycardia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dysphagia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypoxia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Sore Throat | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Allergic Reaction | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Alanine Aminotransferase Increased | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Central line incision site erythema | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Soft Tissue Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Aspartate Aminotransferase Increased | 6 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Typhlitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - nodule | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Right neck rash | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Abdominal Distension | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Pleural Effusion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg nodules | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Purulence at site of prior picc line | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Activated Partial Thromboplastin Time Prolonged | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypokalemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Petechial rash | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L skin lesion (Wrist) | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Acute Kidney Injury | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L Ankle lesion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Erythema around line insertion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Alkaline Phosphatase Increased | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Syncope | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Back Lesion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Alkalosis | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Edema Limbs | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Sinus Tachycardia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Sinus Bradycardia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Sepsis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Scrotal Pain | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Anal fissure | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Localized Edema | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Rhinorrhea | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Retinal Tear | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Anal Fistula | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Soft Tissue Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Restlessness | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Respiratory Failure | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Atrial Flutter | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypocalcemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Hemoptysis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Rectal Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Back Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypoalbuminemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Rectal Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Rash Maculo-papular | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Bacteremia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypertension | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Purpura | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pruritus | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Bloating | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Muscle Cramp | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Proteinuria | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Productive Cough | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood Bicarbonate Decreased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hyperkalemia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Proctitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Presyncope | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood Bilirubin Increased | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Muscle Weakness Upper Limb | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pleuritic Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pleural Effusion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - D Dimer increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Neutrophil Count Decreased | 7 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pharyngitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Peripheral Sensory Neuropathy | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - Increased Fibrinogen | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hematuria | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Periodontal Disease | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pericardial Effusion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - PT increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Heart Failure | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Papulopustular Rash | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pain in Extremity | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR) | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - melena | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Oral Pain | 2 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - petechiae | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - Diverticulitis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Oral Hemorrhage | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Non-cardiac Chest Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Burred Vision | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Paresthesia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Nervous system - Other - Rigors | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Nervous system - Other - Anomia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Bone Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Neck Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Nausea | 6 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Cardiac Troponin I Increased | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Flatulence | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Nasal Congestion | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Myalgia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Catheter Related Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Febrile Neutropenia | 5 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - vastus lateralis muscle strain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Pain in LLE | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Chest Wall Pain | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Peripheral Motor Neuropathy | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Deep tissue injury (buttocks) | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks) | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Chills | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Fatigue | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Mucositis Oral | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Lymphocyte Count Increased | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Chronic Kidney Disease | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Fall | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Lymphocyte Count Decreased | 5 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Lymph Node Pain | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Confusion | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Platelet Count Decreased | 7 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Lung Infection | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - increased chloride | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Constipation | 4 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dyspepsia | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - Increased Fibrinogen | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - Hyperfibrinogenemia | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Cough | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Eye disorders - Other, specify - Right eye vision lost | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Insomnia | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left supraorbital laceration | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Creatinine Increased | 3 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Epistaxis | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left inferior orbital wall fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left frontal bone fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Cytokine Release Syndrome | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Disseminated Intravascular Coagulation | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Pulmonary Edema | 1 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - bilateral nasal bone fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Septal fracture | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | Dehydration | 0 participants |
| Safety Run In DL1 (14 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Skin Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Thrush | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Gastrointestinal bleeding | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dyspepsia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Ear Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Flatulence | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Wet Purpura | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Gastrointestinal Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Genital Edema | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypertension | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Central line incision site erythema | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Neutrophil Count Decreased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Localized Edema | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Paresthesia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pleuritic Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pulmonary Edema | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pulmonary Hypertension | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal dryness | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Retinal Tear | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Petechial rash | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg subcu nodules | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Vaginal Hemorrhage | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Cardiac Arrest | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Eosinophilia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypotension | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Infections & infestations - Other - Sepsis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Lung Infection | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Nausea | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Sinus Bradycardia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Supraventricular Tachycardia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Upper Gastrointestinal Hemorrhage | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Vascular Access Complication | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Vomiting | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Allergic Reaction | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Alopecia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Bone Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Bruising | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Cytokine Release Syndrome | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dysphagia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Alanine Aminotransferase Increased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Aspartate Aminotransferase Increased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Abdominal Distension | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Activated Partial Thromboplastin Time Prolonged | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Acute Kidney Injury | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Alkaline Phosphatase Increased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Alkalosis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Anal fissure | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Anal Fistula | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Atrial Flutter | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Back Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Bacteremia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Bloating | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood Bicarbonate Decreased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood Bilirubin Increased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - D Dimer increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - Increased Fibrinogen | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - PT increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR) | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - petechiae | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Burred Vision | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Cardiac Troponin I Increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Catheter Related Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Chest Wall Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Chills | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Chronic Kidney Disease | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Confusion | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Constipation | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Cough | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Creatinine Increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Disseminated Intravascular Coagulation | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dehydration | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Delirium | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Delusions | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Depression | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Diarrhea | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dizziness | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dry Mouth | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dysgeusia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Dyspnea | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | EKG QT Corrected Interval Prolong | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Ear and Labyrinth - Other - Serous otitis media | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Edema Face | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Edema Limbs | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Elevated Lactate Dehydrogenase (LDH) | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Eosinophilia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Epistaxis | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Esophageal Hemorrhage | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Extrapyramidal Disorder | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Fall | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Fatigue | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Febrile Neutropenia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Fever | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Fibrinogen Decreased | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Floaters | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Flushing | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Folliculitis | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Gamma-Glutamyl Transferase (GGT) Increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Black lesion on tongue | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Bright red blood per rectum | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Diverticulitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Genitourinary bleeding | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Gum Bleeding | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Lip lesion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Lower GI hemmorrage | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Melena | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Rectal bleeding | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - hematochezia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Gastroesophageal reflux disease | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Generalized Edema | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Generalized Muscle Weakness | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Headache | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hearing Impaired | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Heart Failure | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hematoma | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hematuria | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hemorrhoidal Hemorrhage | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hemorrhoids | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hoarseness | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypercalcemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hyperglycemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hyperhidrosis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hyperkalemia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypermagnesemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypernatremia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hyperphosphatemia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hyperuricemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypoalbuminemia | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypocalcemia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypokalemia | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypomagnesemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hyponatremia | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypophosphatemia | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypotension | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Hypoxia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | International Normalized Ratio (INR) Increased | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Pediculosis captis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Sars-COV-2 | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Sepsis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Infusion Related Reaction | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RLE DVT | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep) | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - L nasal dorsum laceration | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Left lateral orbital wall fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Septal fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - bilateral nasal bone fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left frontal bone fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left inferior orbital wall fracture | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left supraorbital laceration | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Insomnia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - Hyperfibrinogenemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - Increased Fibrinogen | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - increased chloride | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Lung Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Lymph Node Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Lymphocyte Count Decreased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Lymphocyte Count Increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Mucositis Oral | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Muscle Cramp | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Muscle Weakness Upper Limb | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks) | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Deep tissue injury (buttocks) | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Pain in LLE | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - vastus lateralis muscle strain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Myalgia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Nasal Congestion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Nausea | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Neck Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Nervous system - Other - Anomia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Nervous system - Other - Rigors | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Non-cardiac Chest Pain | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Oral Hemorrhage | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Oral Pain | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pain | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pain in Extremity | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Papulopustular Rash | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pericardial Effusion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Periodontal Disease | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Peripheral Motor Neuropathy | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Peripheral Sensory Neuropathy | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pharyngitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Platelet Count Decreased | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pleural Effusion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Presyncope | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Proctitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Productive Cough | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Proteinuria | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Pruritus | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Purpura | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Rash Maculo-papular | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Rectal Hemorrhage | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Rectal Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Hemoptysis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal irritation | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Respiratory Failure | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Restlessness | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Rhinorrhea | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Scrotal Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Sepsis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Sinus Bradycardia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Sinus Tachycardia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Back Lesion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Erythema around line insertion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L Ankle lesion | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L skin lesion (Wrist) | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Purulence at site of prior picc line | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg nodules | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Right neck rash | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - nodule | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Skin Infection | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Soft Tissue Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Sore Throat | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Supraventricular Tachycardia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Thromboembolic Event | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Tremor | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Typhlitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Upper Gastrointestinal Hemorrhage | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Upper Respiratory Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Urinary Frequency | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Urinary Incontinence | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Urinary Retention | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Urinary Urgency | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Vaginal Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Vascular Access Complication | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Ventricular Arrhythmia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Vomiting | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Weight Gain | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Weight Loss | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | Wheezing | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | White Blood Cell Decreased | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Alanine Aminotransferase (ALT) Increased | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Acute Respiratory Distress Syndrome (ARDS) | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Aspartate Aminotransferase (AST) Increased | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Abdominal Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Activated Partial Thromboplastin Time (PTT) Prolonged | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Acute Kidney Injury | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Alkaline phosphatase increased | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Anemia | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Anorexia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Anxiety | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Atrial Fibrillation | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Atrial Flutter | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Blood Bilirubin Increased | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Catheter Related Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Creatinine Incrased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Delirium | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Disease Progression | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Dyspnea | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] EKG QT corrected interval prolong | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Epistaxis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Eye disorders - Other, specify - Right eye vision lost | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Fall | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Fatigue | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Febrile Neutropenia | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - Diverticulitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - melena | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Heart Failure | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hematuria | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hyperkalemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypertension | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypoalbuminemia | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypocalcemia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypokalemia | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Hypoxia | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Lymphocyte Count Decreased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Lymphocyte Count Increased | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Neutrophil Count Decreased | 2 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Platelet Count Decreased | 3 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Pleural Effusion | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Pulmonary Edema | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Rash Maculo-papular | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Rectal Pain | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Renal Calculi | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Respiratory Failure | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Seizure | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Sepsis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Sinusitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Skin Infection | 1 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Soft Tissue Infection | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Syncope | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Typhlitis | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] Urinary Retention | 0 participants |
| Safety Run In DL-1 (10 Days Pomalidomide) | Incidence of Adverse Events | [SAE] White Blood Cell Decreased | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dehydration | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Epistaxis | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Septal fracture | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Disseminated Intravascular Coagulation | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - bilateral nasal bone fracture | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pleuritic Pain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left frontal bone fracture | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Creatinine Increased | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Wet Purpura | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left inferior orbital wall fracture | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Eye disorders - Other, specify - Right eye vision lost | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - left supraorbital laceration | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Cough | 7 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Insomnia | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - Hyperfibrinogenemia | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Constipation | 12 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - Increased Fibrinogen | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Fall | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Investigations - Other, specify - increased chloride | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Confusion | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Lung Infection | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pharyngitis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Lymph Node Pain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Chronic Kidney Disease | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Sepsis | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Lymphocyte Count Decreased | 12 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Fatigue | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Lymphocyte Count Increased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Chills | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Muscle Cramp | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Sinus Bradycardia | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Muscle Weakness Upper Limb | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Febrile Neutropenia | 14 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks) | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Chest Wall Pain | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Deep tissue injury (buttocks) | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Pain in LLE | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Catheter Related Infection | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - vastus lateralis muscle strain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - Diverticulitis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Myalgia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Cardiac Troponin I Increased | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Nasal Congestion | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Nausea | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Bruising | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Neck Pain | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - melena | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Nervous system - Other - Anomia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Burred Vision | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Nervous system - Other - Rigors | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Non-cardiac Chest Pain | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - petechiae | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] White Blood Cell Decreased | 16 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Oral Hemorrhage | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Heart Failure | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Oral Pain | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR) | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pain | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Neutrophil Count Decreased | 11 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pain in Extremity | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - PT increased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Diverticulitis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Papulopustular Rash | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Paresthesia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hematuria | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pericardial Effusion | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - Increased Fibrinogen | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Periodontal Disease | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Peripheral Motor Neuropathy | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Urinary Retention | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Peripheral Sensory Neuropathy | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood/Lymph - Other - D Dimer increased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hyperkalemia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Platelet Count Decreased | 16 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pleural Effusion | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood Bilirubin Increased | 6 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Skin Infection | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Presyncope | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Blood Bicarbonate Decreased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hypertension | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Proctitis | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Productive Cough | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Bloating | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Mucositis Oral | 9 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Proteinuria | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pruritus | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pulmonary Edema | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Bacteremia | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hypoalbuminemia | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Purpura | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Rash Maculo-papular | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Back Pain | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Localized Edema | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Rectal Hemorrhage | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Rectal Pain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Atrial Flutter | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hypocalcemia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Hemoptysis | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal dryness | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal irritation | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Respiratory Failure | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Anal Fistula | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Restlessness | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Anal fissure | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hypokalemia | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Rhinorrhea | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Central line incision site erythema | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Scrotal Pain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Alopecia | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Sepsis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Sinus Bradycardia | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Alkalosis | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Sinus Tachycardia | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Soft Tissue Infection | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Alkaline Phosphatase Increased | 7 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hypoxia | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Back Lesion | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Erythema around line insertion | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Acute Kidney Injury | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L Ankle lesion | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L skin lesion (Wrist) | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Activated Partial Thromboplastin Time Prolonged | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypokalemia | 10 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Purulence at site of prior picc line | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Abdominal Distension | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg nodules | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Lymphocyte Count Decreased | 11 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Right neck rash | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Aspartate Aminotransferase Increased | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - nodule | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin Infection | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Alanine Aminotransferase Increased | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Supraventricular Tachycardia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Soft Tissue Infection | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Lymphocyte Count Increased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Sore Throat | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Supraventricular Tachycardia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dyspepsia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Nausea | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Thromboembolic Event | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dysgeusia | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Thrush | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Cytokine Release Syndrome | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Tremor | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypertension | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Typhlitis | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Bone Pain | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Upper Gastrointestinal Hemorrhage | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Neutrophil Count Decreased | 12 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Upper Respiratory Infection | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Allergic Reaction | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Urinary Frequency | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Urinary Incontinence | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Vomiting | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Urinary Retention | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Platelet Count Decreased | 17 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Urinary Urgency | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Vascular Access Complication | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Vaginal Pain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Upper Gastrointestinal Hemorrhage | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Gastrointestinal bleeding | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Vascular Access Complication | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Syncope | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Pleural Effusion | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Ventricular Arrhythmia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Vomiting | 6 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Sinusitis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hemorrhoids | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Weight Gain | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Weight Loss | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Pulmonary Edema | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Wheezing | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Lung Infection | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | White Blood Cell Decreased | 16 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Infections & infestations - Other - Sepsis | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Genital Edema | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Alanine Aminotransferase (ALT) Increased | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Hypotension | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Edema Face | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Acute Respiratory Distress Syndrome (ARDS) | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Rash Maculo-papular | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Aspartate Aminotransferase (AST) Increased | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Eosinophilia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Abdominal Pain | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Activated Partial Thromboplastin Time (PTT) Prolonged | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] EKG QT corrected interval prolong | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Acute Kidney Injury | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Rectal Pain | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Alkaline phosphatase increased | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Flushing | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Blood Bilirubin Increased | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Folliculitis | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Gamma-Glutamyl Transferase (GGT) Increased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Floaters | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Anemia | 13 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Black lesion on tongue | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Bright red blood per rectum | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Flatulence | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Fibrinogen Decreased | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Gastrointestinal Pain | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Genitourinary bleeding | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Anorexia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Gum Bleeding | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Fever | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Lip lesion | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Vaginal Hemorrhage | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Lower GI hemmorrage | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Febrile Neutropenia | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Typhlitis | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Melena | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Anxiety | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - Rectal bleeding | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Fatigue | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | GI disorders - Other, specify - hematochezia | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg subcu nodules | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Fall | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Renal Calculi | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Generalized Edema | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Atrial Fibrillation | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Generalized Muscle Weakness | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Extrapyramidal Disorder | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Headache | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Esophageal Hemorrhage | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hearing Impaired | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Heart Failure | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Epistaxis | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Atrial Flutter | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hematoma | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hematuria | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Eosinophilia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Petechial rash | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hemorrhoidal Hemorrhage | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Cardiac Arrest | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hoarseness | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Elevated Lactate Dehydrogenase (LDH) | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypercalcemia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hyperglycemia | 6 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Edema Limbs | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hyperhidrosis | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Catheter Related Infection | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hyperkalemia | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Ear Pain | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypermagnesemia | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Ear and Labyrinth - Other - Serous otitis media | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypernatremia | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Respiratory Failure | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hyperphosphatemia | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | EKG QT Corrected Interval Prolong | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Creatinine Incrased | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hyperuricemia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dyspnea | 9 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypoalbuminemia | 12 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypocalcemia | 8 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dysphagia | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Delirium | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypomagnesemia | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hyponatremia | 7 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dry Mouth | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Retinal Tear | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypophosphatemia | 5 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Gastroesophageal reflux disease | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypotension | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Dizziness | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Disease Progression | 2 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Hypoxia | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | International Normalized Ratio (INR) Increased | 3 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Diarrhea | 6 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Pediculosis captis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Sars-COV-2 | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Depression | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Dyspnea | 4 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Infections & infestations - Other - Sepsis | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Infusion Related Reaction | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Delusions | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RLE DVT | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | [SAE] Seizure | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep) | 1 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Delirium | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Pulmonary Hypertension | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - L nasal dorsum laceration | 0 participants |
| Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) | Incidence of Adverse Events | Injury/poison/procedure - Other - Left lateral orbital wall fracture | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal dryness | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Thrush | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Disseminated Intravascular Coagulation | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Upper Respiratory Infection | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - hematochezia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - Septal fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Nausea | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Epistaxis | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Fall | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - bilateral nasal bone fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Creatinine Increased | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Tremor | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Bone Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - left frontal bone fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Delirium | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hyperuricemia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Typhlitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - left inferior orbital wall fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Cough | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Infections & infestations - Other - Pediculosis captis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Supraventricular Tachycardia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - left supraorbital laceration | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Creatinine Incrased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Eye disorders - Other, specify - Right eye vision lost | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Upper Gastrointestinal Hemorrhage | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Insomnia | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Constipation | 10 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pharyngitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Allergic Reaction | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Investigations - Other, specify - Hyperfibrinogenemia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Generalized Edema | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dysgeusia | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Extrapyramidal Disorder | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Investigations - Other, specify - Increased Fibrinogen | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Confusion | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Depression | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Neutrophil Count Decreased | 11 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Investigations - Other, specify - increased chloride | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Localized Edema | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypoalbuminemia | 14 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Fall | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Urinary Frequency | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Lung Infection | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Chronic Kidney Disease | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Vomiting | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hemorrhoids | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Lymph Node Pain | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Generalized Muscle Weakness | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Urinary Incontinence | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Genital Edema | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Lymphocyte Count Decreased | 13 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Chills | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Edema Face | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dysphagia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Lymphocyte Count Increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Urinary Retention | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Fatigue | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Periodontal Disease | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Vascular Access Complication | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Atrial Fibrillation | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Retinal Tear | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Muscle Weakness Upper Limb | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Chest Wall Pain | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Urinary Urgency | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Headache | 7 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks) | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Upper Gastrointestinal Hemorrhage | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Febrile Neutropenia | 16 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Platelet Count Decreased | 13 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Deep tissue injury (buttocks) | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Catheter Related Infection | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Papulopustular Rash | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Ear and Labyrinth - Other - Serous otitis media | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - Pain in LLE | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Vaginal Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Sinus Bradycardia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Petechial rash | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Musculoskel/connect tissue -Other - vastus lateralis muscle strain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Cardiac Troponin I Increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypocalcemia | 9 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hearing Impaired | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Myalgia | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Vascular Access Complication | 9 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - Diverticulitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Epistaxis | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Nasal Congestion | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Bruising | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Non-cardiac Chest Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Renal Calculi | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Nausea | 8 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - Left lateral orbital wall fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Diverticulitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Ventricular Arrhythmia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Neck Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Burred Vision | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Sinusitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Pleural Effusion | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Nervous system - Other - Anomia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Heart Failure | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] GI disorders - Other, specify - melena | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Vomiting | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Nervous system - Other - Rigors | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Neutrophil Count Decreased | 11 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood/Lymph - Other - petechiae | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Respiratory Failure | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Infections & infestations - Other - Sars-COV-2 | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - L nasal dorsum laceration | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Weight Gain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Oral Hemorrhage | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR) | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Sepsis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Syncope | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Oral Pain | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hematoma | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Heart Failure | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Weight Loss | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pain | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood/Lymph - Other - PT increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Lung Infection | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Eosinophilia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pain in Extremity | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Atrial Flutter | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Wheezing | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypomagnesemia | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Pulmonary Edema | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Paresthesia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood/Lymph - Other - Increased Fibrinogen | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hematuria | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | White Blood Cell Decreased | 14 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pericardial Effusion | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dry Mouth | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hematuria | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Delirium | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Muscle Cramp | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep) | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Peripheral Motor Neuropathy | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood/Lymph - Other - D Dimer increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Alanine Aminotransferase (ALT) Increased | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hemorrhoidal Hemorrhage | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Peripheral Sensory Neuropathy | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Elevated Lactate Dehydrogenase (LDH) | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Gastroesophageal reflux disease | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hyperkalemia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Acute Respiratory Distress Syndrome (ARDS) | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Platelet Count Decreased | 12 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood Bilirubin Increased | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Mucositis Oral | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Eosinophilia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pleural Effusion | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hyponatremia | 10 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Blood Bicarbonate Decreased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dehydration | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Aspartate Aminotransferase (AST) Increased | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Presyncope | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hoarseness | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Rash Maculo-papular | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Infections & infestations - Other - Sepsis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Proctitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Bloating | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hypertension | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Abdominal Pain | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Productive Cough | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] EKG QT corrected interval prolong | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Gastrointestinal Pain | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Cardiac Arrest | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Proteinuria | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Bacteremia | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Skin Infection | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Activated Partial Thromboplastin Time (PTT) Prolonged | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pruritus | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Delusions | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pulmonary Edema | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pulmonary Hypertension | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] White Blood Cell Decreased | 15 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypercalcemia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Acute Kidney Injury | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Purpura | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Back Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hypoalbuminemia | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Blood Bilirubin Increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Rash Maculo-papular | 8 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Edema Limbs | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Alkaline phosphatase increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Rectal Hemorrhage | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Atrial Flutter | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Fibrinogen Decreased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Flushing | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypophosphatemia | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hyperglycemia | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dizziness | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Hemoptysis | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Folliculitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hypocalcemia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Floaters | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Resp, thoracic & mediast - Other - Nasal irritation | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Anal Fistula | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - Central line incision site erythema | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Rectal Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Respiratory Failure | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Typhlitis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Urinary Retention | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Gamma-Glutamyl Transferase (GGT) Increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Restlessness | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Anal fissure | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Dyspnea | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hyperhidrosis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Ear Pain | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Rhinorrhea | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Alopecia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Black lesion on tongue | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Flatulence | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Scrotal Pain | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Anemia | 11 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hypokalemia | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Sore Throat | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Sepsis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Alkalosis | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hypotension | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Bright red blood per rectum | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Sinus Bradycardia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypotension | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypoxia | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Vaginal Hemorrhage | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Sinus Tachycardia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Alkaline Phosphatase Increased | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Gastrointestinal bleeding | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hyperkalemia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Infusion Related Reaction | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Catheter Related Infection | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Back Lesion | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Acute Kidney Injury | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Hypoxia | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Genitourinary bleeding | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Erythema around line insertion | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Fever | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Infections & infestations - Other - Sepsis | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Pleuritic Pain | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L Ankle lesion | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Activated Partial Thromboplastin Time Prolonged | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypokalemia | 11 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypermagnesemia | 2 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - L skin lesion (Wrist) | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Gum Bleeding | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Abdominal Distension | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Rectal Pain | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Anorexia | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Purulence at site of prior picc line | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Diarrhea | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Soft Tissue Infection | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Lip lesion | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg nodules | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - R leg subcu nodules | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Aspartate Aminotransferase Increased | 8 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Febrile Neutropenia | 4 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Disease Progression | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - Right neck rash | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypernatremia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Lymphocyte Count Decreased | 12 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Lower GI hemmorrage | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin & subcutaneous tissue -Other - nodule | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Alanine Aminotransferase Increased | 8 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hypertension | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | EKG QT Corrected Interval Prolong | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Skin Infection | 3 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Seizure | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | International Normalized Ratio (INR) Increased | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Melena | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Soft Tissue Infection | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Esophageal Hemorrhage | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Fatigue | 6 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Hyperphosphatemia | 5 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dyspepsia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Lymphocyte Count Increased | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Injury/poison/procedure - Other - Acute RLE DVT | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Supraventricular Tachycardia | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Rectal bleeding | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | GI disorders - Other, specify - Wet Purpura | 0 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Dyspnea | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Thromboembolic Event | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | [SAE] Anxiety | 1 participants |
| Arm B (Daunorubicin and Cytarabine Liposome) | Incidence of Adverse Events | Cytokine Release Syndrome | 0 participants |
Secondary
Overall Survival (OS)
Will be compared between Arms A and B.
Time frame: From randomization until death or last follow-up, assessed up to 5 years
Secondary
Rate of Allogeneic Stem Cell Transplantation
Will be compared between Arms A and B.
Time frame: Up to 5 years