Trial Outcomes & Findings for Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes (NCT NCT04802161)
NCT ID: NCT04802161
Last Updated: 2025-12-19
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-12-19
Participant Flow
One participant who was consented to the study declined to participate before being randomized to an arm.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
20
|
19
|
|
Overall Study
COMPLETED
|
6
|
3
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
Alternate Therapy prior to Day 21
|
1
|
0
|
1
|
1
|
|
Overall Study
Clinical Instability
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes
Baseline characteristics by cohort
| Measure |
Safety Run In DL1 (14 Days Pomalidomide)
n=6 Participants
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
|
Safety Run In DL-1 (10 Days Pomalidomide)
n=3 Participants
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
|
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
n=16 Participants
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
|
Arm B (Daunorubicin and Cytarabine Liposome)
n=18 Participants
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
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.5 years
n=8 Participants
|
66 years
n=6 Participants
|
63 years
n=6 Participants
|
63 years
n=9 Participants
|
63 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
26 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
17 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
42 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=8 Participants
|
3 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
35 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=8 Participants
|
3 participants
n=6 Participants
|
16 participants
n=6 Participants
|
18 participants
n=9 Participants
|
43 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: This outcome measure was not reported on for the safety run-in phase
Outcome measures
| Measure |
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
|
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
|
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
n=16 Participants
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
|
Arm B (Daunorubicin and Cytarabine Liposome)
n=18 Participants
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
|
|---|---|---|---|---|
|
Rate of Complete Response (CR)/Complete Response With Incomplete Hematologic Recovery (CRi)
|
—
|
—
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be assessed and compared with both arms A and B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after last dose, up to 2 yearsWill 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 "\[SAE\]".
Outcome measures
| Measure |
Safety Run In DL1 (14 Days Pomalidomide)
n=7 Participants
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
|
Safety Run In DL-1 (10 Days Pomalidomide)
n=3 Participants
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
|
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
n=20 Participants
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
|
Arm B (Daunorubicin and Cytarabine Liposome)
n=19 Participants
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
|
|---|---|---|---|---|
|
Incidence of Adverse Events
Floaters
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Flushing
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Folliculitis
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Gamma-Glutamyl Transferase (GGT) Increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Pain in Extremity
|
0 participants
|
1 participants
|
1 participants
|
4 participants
|
|
Incidence of Adverse Events
Papulopustular Rash
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Black lesion on tongue
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Bright red blood per rectum
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Diverticulitis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Gastrointestinal bleeding
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Genitourinary bleeding
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Paresthesia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Gum Bleeding
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Lip lesion
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Lower GI hemmorrage
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Melena
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Rectal bleeding
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Pericardial Effusion
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - Wet Purpura
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
GI disorders - Other, specify - hematochezia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Gastroesophageal reflux disease
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Gastrointestinal Pain
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Generalized Edema
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Generalized Muscle Weakness
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
|
Incidence of Adverse Events
Genital Edema
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Headache
|
2 participants
|
2 participants
|
5 participants
|
7 participants
|
|
Incidence of Adverse Events
Hearing Impaired
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Heart Failure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Hematoma
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Hematuria
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Incidence of Adverse Events
Musculoskel/connect tissue -Other - Pain in LLE
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Musculoskel/connect tissue -Other - vastus lateralis muscle strain
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Myalgia
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Nasal Congestion
|
3 participants
|
0 participants
|
1 participants
|
6 participants
|
|
Incidence of Adverse Events
Nausea
|
6 participants
|
2 participants
|
8 participants
|
8 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - L nasal dorsum laceration
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Neck Pain
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - Left lateral orbital wall fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Nervous system - Other - Anomia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Alanine Aminotransferase Increased
|
4 participants
|
2 participants
|
8 participants
|
8 participants
|
|
Incidence of Adverse Events
Aspartate Aminotransferase Increased
|
6 participants
|
2 participants
|
8 participants
|
8 participants
|
|
Incidence of Adverse Events
Abdominal Distension
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Activated Partial Thromboplastin Time Prolonged
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Nervous system - Other - Rigors
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Acute Kidney Injury
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Alkaline Phosphatase Increased
|
4 participants
|
2 participants
|
7 participants
|
4 participants
|
|
Incidence of Adverse Events
Alkalosis
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Allergic Reaction
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Alopecia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Anal fissure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Anal Fistula
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Atrial Flutter
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - Septal fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - bilateral nasal bone fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Neutrophil Count Decreased
|
7 participants
|
2 participants
|
11 participants
|
11 participants
|
|
Incidence of Adverse Events
Back Pain
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Bacteremia
|
1 participants
|
1 participants
|
4 participants
|
5 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - left frontal bone fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Bloating
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Blood Bicarbonate Decreased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Blood Bilirubin Increased
|
4 participants
|
2 participants
|
6 participants
|
3 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - left inferior orbital wall fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Blood/Lymph - Other - D Dimer increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Blood/Lymph - Other - Increased Fibrinogen
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Blood/Lymph - Other - PT increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - left supraorbital laceration
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Non-cardiac Chest Pain
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Blood/Lymph - Other - petechiae
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Burred Vision
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Incidence of Adverse Events
Insomnia
|
3 participants
|
1 participants
|
5 participants
|
5 participants
|
|
Incidence of Adverse Events
Investigations - Other, specify - Hyperfibrinogenemia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Investigations - Other, specify - Increased Fibrinogen
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Bone Pain
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Bruising
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Cardiac Troponin I Increased
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Catheter Related Infection
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Chest Wall Pain
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Chills
|
0 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Incidence of Adverse Events
Chronic Kidney Disease
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Confusion
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Constipation
|
4 participants
|
0 participants
|
12 participants
|
10 participants
|
|
Incidence of Adverse Events
Investigations - Other, specify - increased chloride
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Oral Hemorrhage
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Cough
|
0 participants
|
3 participants
|
7 participants
|
5 participants
|
|
Incidence of Adverse Events
Creatinine Increased
|
3 participants
|
0 participants
|
4 participants
|
3 participants
|
|
Incidence of Adverse Events
Cytokine Release Syndrome
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Localized Edema
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Lung Infection
|
0 participants
|
0 participants
|
2 participants
|
5 participants
|
|
Incidence of Adverse Events
Lymph Node Pain
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Lymphocyte Count Decreased
|
5 participants
|
2 participants
|
12 participants
|
13 participants
|
|
Incidence of Adverse Events
Disseminated Intravascular Coagulation
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Dehydration
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Delirium
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Delusions
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Lymphocyte Count Increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Mucositis Oral
|
3 participants
|
1 participants
|
9 participants
|
5 participants
|
|
Incidence of Adverse Events
Depression
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Muscle Cramp
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Diarrhea
|
2 participants
|
1 participants
|
6 participants
|
4 participants
|
|
Incidence of Adverse Events
Muscle Weakness Upper Limb
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Dizziness
|
1 participants
|
1 participants
|
4 participants
|
4 participants
|
|
Incidence of Adverse Events
Dry Mouth
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Dysgeusia
|
0 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Incidence of Adverse Events
Oral Pain
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Incidence of Adverse Events
Pain
|
0 participants
|
1 participants
|
5 participants
|
6 participants
|
|
Incidence of Adverse Events
Dyspepsia
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Dysphagia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Musculoskel/connect tissue -Other - Deep tissue injury (buttocks)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Dyspnea
|
2 participants
|
1 participants
|
9 participants
|
1 participants
|
|
Incidence of Adverse Events
EKG QT Corrected Interval Prolong
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Ear and Labyrinth - Other - Serous otitis media
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Ear Pain
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Edema Face
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Edema Limbs
|
2 participants
|
2 participants
|
8 participants
|
6 participants
|
|
Incidence of Adverse Events
Elevated Lactate Dehydrogenase (LDH)
|
1 participants
|
1 participants
|
3 participants
|
4 participants
|
|
Incidence of Adverse Events
Epistaxis
|
1 participants
|
2 participants
|
5 participants
|
6 participants
|
|
Incidence of Adverse Events
Esophageal Hemorrhage
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Extrapyramidal Disorder
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Fall
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Fatigue
|
3 participants
|
3 participants
|
8 participants
|
6 participants
|
|
Incidence of Adverse Events
Febrile Neutropenia
|
2 participants
|
1 participants
|
8 participants
|
4 participants
|
|
Incidence of Adverse Events
Fever
|
1 participants
|
1 participants
|
4 participants
|
4 participants
|
|
Incidence of Adverse Events
Fibrinogen Decreased
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Flatulence
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Incidence of Adverse Events
Tremor
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Typhlitis
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
Upper Gastrointestinal Hemorrhage
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Upper Respiratory Infection
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Urinary Frequency
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Urinary Incontinence
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Urinary Retention
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Urinary Urgency
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Vaginal Hemorrhage
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Vaginal Pain
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Vascular Access Complication
|
2 participants
|
0 participants
|
8 participants
|
9 participants
|
|
Incidence of Adverse Events
Ventricular Arrhythmia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Vomiting
|
2 participants
|
1 participants
|
6 participants
|
4 participants
|
|
Incidence of Adverse Events
Weight Gain
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Weight Loss
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Wheezing
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
White Blood Cell Decreased
|
5 participants
|
3 participants
|
16 participants
|
14 participants
|
|
Incidence of Adverse Events
[SAE] Blood Bilirubin Increased
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Alanine Aminotransferase (ALT) Increased
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Acute Respiratory Distress Syndrome (ARDS)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Cardiac Arrest
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Aspartate Aminotransferase (AST) Increased
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Incidence of Adverse Events
[SAE] Abdominal Pain
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Activated Partial Thromboplastin Time (PTT) Prolonged
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Catheter Related Infection
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Acute Kidney Injury
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Alkaline phosphatase increased
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Anemia
|
7 participants
|
3 participants
|
13 participants
|
11 participants
|
|
Incidence of Adverse Events
[SAE] Anorexia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Anxiety
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Periodontal Disease
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Peripheral Motor Neuropathy
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Peripheral Sensory Neuropathy
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
Pharyngitis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Platelet Count Decreased
|
7 participants
|
3 participants
|
16 participants
|
12 participants
|
|
Incidence of Adverse Events
Pleural Effusion
|
0 participants
|
0 participants
|
4 participants
|
5 participants
|
|
Incidence of Adverse Events
Pleuritic Pain
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Presyncope
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Proctitis
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Productive Cough
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Proteinuria
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Pruritus
|
1 participants
|
1 participants
|
4 participants
|
6 participants
|
|
Incidence of Adverse Events
Pulmonary Edema
|
1 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
Pulmonary Hypertension
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Purpura
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Rash Maculo-papular
|
4 participants
|
1 participants
|
8 participants
|
8 participants
|
|
Incidence of Adverse Events
Rectal Hemorrhage
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Rectal Pain
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Incidence of Adverse Events
Resp, thoracic & mediast - Other - Hemoptysis
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Resp, thoracic & mediast - Other - Nasal dryness
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Resp, thoracic & mediast - Other - Nasal irritation
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Atrial Fibrillation
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Respiratory Failure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Restlessness
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Retinal Tear
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Rhinorrhea
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Scrotal Pain
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Sepsis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Sinus Bradycardia
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
Sinus Tachycardia
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - Back Lesion
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - Erythema around line insertion
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - L Ankle lesion
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Atrial Flutter
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - L skin lesion (Wrist)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - Petechial rash
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - Purulence at site of prior picc line
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - R leg nodules
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - R leg subcu nodules
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - Right neck rash
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Skin & subcutaneous tissue -Other - nodule
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Skin Infection
|
0 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Incidence of Adverse Events
Soft Tissue Infection
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Sore Throat
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Supraventricular Tachycardia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Thromboembolic Event
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Thrush
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Hypoxia
|
0 participants
|
0 participants
|
8 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Infections & infestations - Other - Sepsis
|
2 participants
|
0 participants
|
4 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Lung Infection
|
1 participants
|
2 participants
|
3 participants
|
4 participants
|
|
Incidence of Adverse Events
[SAE] Lymphocyte Count Decreased
|
4 participants
|
2 participants
|
11 participants
|
12 participants
|
|
Incidence of Adverse Events
[SAE] Lymphocyte Count Increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Nausea
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Neutrophil Count Decreased
|
7 participants
|
2 participants
|
12 participants
|
11 participants
|
|
Incidence of Adverse Events
[SAE] Platelet Count Decreased
|
7 participants
|
3 participants
|
17 participants
|
13 participants
|
|
Incidence of Adverse Events
[SAE] Pleural Effusion
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Pulmonary Edema
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Rash Maculo-papular
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Rectal Pain
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Renal Calculi
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Respiratory Failure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Seizure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Sepsis
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Sinus Bradycardia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Sinusitis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Skin Infection
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Soft Tissue Infection
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Supraventricular Tachycardia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Syncope
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Typhlitis
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Upper Gastrointestinal Hemorrhage
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Urinary Retention
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Vascular Access Complication
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Vomiting
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] White Blood Cell Decreased
|
6 participants
|
3 participants
|
16 participants
|
15 participants
|
|
Incidence of Adverse Events
[SAE] Creatinine Incrased
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Delirium
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Disease Progression
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Dyspnea
|
1 participants
|
0 participants
|
4 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] EKG QT corrected interval prolong
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Eosinophilia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Epistaxis
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Eye disorders - Other, specify - Right eye vision lost
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Fall
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
[SAE] Fatigue
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Febrile Neutropenia
|
5 participants
|
3 participants
|
14 participants
|
16 participants
|
|
Incidence of Adverse Events
[SAE] GI disorders - Other, specify - Diverticulitis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] GI disorders - Other, specify - melena
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Heart Failure
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Hematuria
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Hyperkalemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Hypertension
|
0 participants
|
0 participants
|
5 participants
|
4 participants
|
|
Incidence of Adverse Events
[SAE] Hypoalbuminemia
|
1 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Incidence of Adverse Events
[SAE] Hypocalcemia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
[SAE] Hypokalemia
|
1 participants
|
2 participants
|
3 participants
|
4 participants
|
|
Incidence of Adverse Events
[SAE] Hypotension
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Eosinophilia
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Hemorrhoidal Hemorrhage
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Hemorrhoids
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hoarseness
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hypercalcemia
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hyperglycemia
|
1 participants
|
0 participants
|
6 participants
|
6 participants
|
|
Incidence of Adverse Events
Hyperhidrosis
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of Adverse Events
Hyperkalemia
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Incidence of Adverse Events
Hypermagnesemia
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Incidence of Adverse Events
Hypernatremia
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Incidence of Adverse Events
Hypoalbuminemia
|
7 participants
|
3 participants
|
12 participants
|
14 participants
|
|
Incidence of Adverse Events
Hyperphosphatemia
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
|
Incidence of Adverse Events
Hypertension
|
0 participants
|
1 participants
|
5 participants
|
6 participants
|
|
Incidence of Adverse Events
Hyperuricemia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Hypophosphatemia
|
3 participants
|
2 participants
|
5 participants
|
4 participants
|
|
Incidence of Adverse Events
Hypotension
|
0 participants
|
1 participants
|
3 participants
|
3 participants
|
|
Incidence of Adverse Events
Hypocalcemia
|
3 participants
|
1 participants
|
8 participants
|
9 participants
|
|
Incidence of Adverse Events
Hypokalemia
|
6 participants
|
2 participants
|
10 participants
|
11 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Hypomagnesemia
|
2 participants
|
0 participants
|
4 participants
|
3 participants
|
|
Incidence of Adverse Events
Hyponatremia
|
4 participants
|
2 participants
|
7 participants
|
10 participants
|
|
Incidence of Adverse Events
Hypoxia
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
|
Incidence of Adverse Events
International Normalized Ratio (INR) Increased
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - Central line incision site erythema
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Infections & infestations - Other - Pediculosis captis
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Infections & infestations - Other - Sars-COV-2
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Infections & infestations - Other - Sepsis
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Incidence of Adverse Events
Infusion Related Reaction
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Incidence of Adverse Events
Injury/poison/procedure - Other - Acute RLE DVT
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill assess CR without MRD by flow cytometry via Hematologics, Inc. compare descriptively between Arms A and B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From day 1 of liposome-encapsulated daunorubicin-cytarabine until no response is achieved, relapse or death, will be assessed for up to 5 yearsWill be compared between Arms A and B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From CR/CRi until relapse or death, assessed at 2 yearsPopulation: This outcome measure was not reported on for the safety run-in phase
Will be compared between Arms A and B.
Outcome measures
| Measure |
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
|
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
|
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
n=16 Participants
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
|
Arm B (Daunorubicin and Cytarabine Liposome)
n=18 Participants
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
|
|---|---|---|---|---|
|
Disease-free Survival (DFS)
|
—
|
—
|
8.18 months
Interval 6.28 to
Upper confidence interval is not available due to insufficient number of events
|
NA months
Median DFS is not available due to insufficient number of events
|
SECONDARY outcome
Timeframe: From CR/CRi until relapse or death, assessed up to 5 yearsWill be compared between Arms A and B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until death or last follow-up, assessed up to 5 yearsWill be compared between Arms A and B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsWill be compared between Arms A and B.
Outcome measures
Outcome data not reported
Adverse Events
Safety Run In DL1 (14 Days Pomalidomide)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 3 deaths
Safety Run In DL-1 (10 Days Pomalidomide)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
Serious events: 19 serious events
Other events: 20 other events
Deaths: 11 deaths
Arm B (Daunorubicin and Cytarabine Liposome)
Serious events: 19 serious events
Other events: 18 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Safety Run In DL1 (14 Days Pomalidomide)
n=7 participants at risk
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
|
Safety Run In DL-1 (10 Days Pomalidomide)
n=3 participants at risk
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
|
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
n=20 participants at risk
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
|
Arm B (Daunorubicin and Cytarabine Liposome)
n=19 participants at risk
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
|
|---|---|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
1/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome (ARDS)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
28.6%
2/7 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
7/7 • Number of events 60 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 21 • Up to 30 days after last dose, up to 2 years
|
65.0%
13/20 • Number of events 76 • Up to 30 days after last dose, up to 2 years
|
57.9%
11/19 • Number of events 49 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 8 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Creatinine increased
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Delirium
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Disease Progression
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
EKG QT corrected interval prolonged
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Eosinophilia
|
14.3%
1/7 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Eye disorders
Eye disorders - Other, specify - Right eye vision lost
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Fall
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
71.4%
5/7 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
70.0%
14/20 • Number of events 34 • Up to 30 days after last dose, up to 2 years
|
84.2%
16/19 • Number of events 27 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - melena
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Diverticulitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Sepsis
|
28.6%
2/7 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Lung Infection
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 11 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Lymphocyte Count Decreased
|
57.1%
4/7 • Number of events 29 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
55.0%
11/20 • Number of events 87 • Up to 30 days after last dose, up to 2 years
|
63.2%
12/19 • Number of events 64 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Lymphocyte Count Increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
7/7 • Number of events 31 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 19 • Up to 30 days after last dose, up to 2 years
|
60.0%
12/20 • Number of events 54 • Up to 30 days after last dose, up to 2 years
|
57.9%
11/19 • Number of events 45 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Platelet count decreased
|
100.0%
7/7 • Number of events 110 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 35 • Up to 30 days after last dose, up to 2 years
|
85.0%
17/20 • Number of events 122 • Up to 30 days after last dose, up to 2 years
|
68.4%
13/19 • Number of events 79 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Renal Calculi
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Skin Infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
White Blood Cell Decreased
|
85.7%
6/7 • Number of events 31 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 32 • Up to 30 days after last dose, up to 2 years
|
80.0%
16/20 • Number of events 86 • Up to 30 days after last dose, up to 2 years
|
78.9%
15/19 • Number of events 73 • Up to 30 days after last dose, up to 2 years
|
Other adverse events
| Measure |
Safety Run In DL1 (14 Days Pomalidomide)
n=7 participants at risk
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
|
Safety Run In DL-1 (10 Days Pomalidomide)
n=3 participants at risk
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
|
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
n=20 participants at risk
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
|
Arm B (Daunorubicin and Cytarabine Liposome)
n=19 participants at risk
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
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
International Normalized Ratio (INR) Increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Pediculosis captis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Sars-COV-2
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Infections & infestations - Other - Sepsis
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Acute RLE DVT
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Central line incision site erythema
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - L nasal dorsum laceration
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
42.9%
3/7 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
45.0%
9/20 • Number of events 14 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 8 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Deep tissue injury (buttocks)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Pain in LLE
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Oral Pain
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Platelet Count Decreased
|
100.0%
7/7 • Number of events 113 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 35 • Up to 30 days after last dose, up to 2 years
|
80.0%
16/20 • Number of events 106 • Up to 30 days after last dose, up to 2 years
|
63.2%
12/19 • Number of events 81 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 8 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Purpura
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
57.1%
4/7 • Number of events 13 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 18 • Up to 30 days after last dose, up to 2 years
|
42.1%
8/19 • Number of events 16 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Hemoptysis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Sepsis
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Back Lesion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Erythema around line insertion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - nodule
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Thrush
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 11 • Up to 30 days after last dose, up to 2 years
|
47.4%
9/19 • Number of events 13 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
30.0%
6/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Weight gain
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Weight loss
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
White blood cell decreased
|
71.4%
5/7 • Number of events 38 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 32 • Up to 30 days after last dose, up to 2 years
|
80.0%
16/20 • Number of events 84 • Up to 30 days after last dose, up to 2 years
|
73.7%
14/19 • Number of events 84 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Cardiac Troponin I Increased
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypophospatemia
|
42.9%
3/7 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 8 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Chills
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
57.1%
4/7 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
60.0%
12/20 • Number of events 21 • Up to 30 days after last dose, up to 2 years
|
52.6%
10/19 • Number of events 11 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
35.0%
7/20 • Number of events 11 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Creatinine Increased
|
42.9%
3/7 • Number of events 16 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation (DIC)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Delirium
|
28.6%
2/7 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Delusions
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
30.0%
6/20 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
45.0%
9/20 • Number of events 19 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
EKG QT corrected interval prolong
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Ear and labyrinth disorders
Ear and Labyrinth - Other - Serous otitis media
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Edema Face
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Edema limbs
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 19 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Elevated Lactate Dehydrogenase
|
14.3%
1/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Eosinophilia
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Fall
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 11 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 19 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
28.6%
2/7 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 15 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Eye disorders
Floaters
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Gamma-Glutamyl Transferase Increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Black lesion on tongue
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Bright red blood per rectum
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Diverticulitis
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Gastrointestinal bleeding
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Genitourinary bleeding
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Gum Bleeding
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Lip lesion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Lower GI hemmorrage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Melena
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Rectal bleeding
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - Wet Purpura
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
GI disorders - Other, specify - hematochezia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 8 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Generalized Edema
|
28.6%
2/7 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Genital Edema
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
36.8%
7/19 • Number of events 15 • Up to 30 days after last dose, up to 2 years
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Hematoma
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarsenes
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
30.0%
6/20 • Number of events 19 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 21 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
28.6%
2/7 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
7/7 • Number of events 49 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 22 • Up to 30 days after last dose, up to 2 years
|
60.0%
12/20 • Number of events 72 • Up to 30 days after last dose, up to 2 years
|
73.7%
14/19 • Number of events 78 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
42.9%
3/7 • Number of events 14 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 22 • Up to 30 days after last dose, up to 2 years
|
47.4%
9/19 • Number of events 26 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
85.7%
6/7 • Number of events 31 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 20 • Up to 30 days after last dose, up to 2 years
|
50.0%
10/20 • Number of events 68 • Up to 30 days after last dose, up to 2 years
|
57.9%
11/19 • Number of events 39 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
4/7 • Number of events 17 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 18 • Up to 30 days after last dose, up to 2 years
|
35.0%
7/20 • Number of events 23 • Up to 30 days after last dose, up to 2 years
|
52.6%
10/19 • Number of events 23 • Up to 30 days after last dose, up to 2 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
57.1%
4/7 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 15 • Up to 30 days after last dose, up to 2 years
|
35.0%
7/20 • Number of events 18 • Up to 30 days after last dose, up to 2 years
|
21.1%
4/19 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Alkalosis
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Immune system disorders
Allergic Reaction
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Anal Fistula
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
7/7 • Number of events 106 • Up to 30 days after last dose, up to 2 years
|
100.0%
3/3 • Number of events 32 • Up to 30 days after last dose, up to 2 years
|
65.0%
13/20 • Number of events 116 • Up to 30 days after last dose, up to 2 years
|
57.9%
11/19 • Number of events 104 • Up to 30 days after last dose, up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 8 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
14.3%
1/7 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Bacteremia
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
20.0%
4/20 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Blood Bicarbonate Decreased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Blood Bilirubin Increased
|
57.1%
4/7 • Number of events 17 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 13 • Up to 30 days after last dose, up to 2 years
|
30.0%
6/20 • Number of events 31 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - D Dimer increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Increased Fibrinogen
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - Prothrombin Time increased
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Blood/Lymph - Other - petechiae
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Eye disorders
Blurred Vision
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
15.8%
3/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
57.1%
4/7 • Number of events 17 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 24 • Up to 30 days after last dose, up to 2 years
|
42.1%
8/19 • Number of events 27 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
85.7%
6/7 • Number of events 25 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 16 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 34 • Up to 30 days after last dose, up to 2 years
|
42.1%
8/19 • Number of events 36 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
30.0%
6/20 • Number of events 12 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Left lateral orbital wall fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Septal fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - bilateral nasal bone fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - left frontal bone fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - left inferior orbital wall fracture
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - left supraorbital laceration
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Psychiatric disorders
Insomnia
|
42.9%
3/7 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
25.0%
5/20 • Number of events 13 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Investigations - Other, specify - Hyperfibrinogenemia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Investigations - Other, specify - Increased Fibrinogen
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Investigations - Other, specify - increased chloride
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
General disorders
Localized edema
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
10.0%
2/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
26.3%
5/19 • Number of events 7 • Up to 30 days after last dose, up to 2 years
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
14.3%
1/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
71.4%
5/7 • Number of events 56 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 31 • Up to 30 days after last dose, up to 2 years
|
60.0%
12/20 • Number of events 114 • Up to 30 days after last dose, up to 2 years
|
68.4%
13/19 • Number of events 127 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - vastus lateralis muscle strain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
10.5%
2/19 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
42.9%
3/7 • Number of events 6 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
31.6%
6/19 • Number of events 10 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Number of events 9 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
40.0%
8/20 • Number of events 11 • Up to 30 days after last dose, up to 2 years
|
42.1%
8/19 • Number of events 17 • Up to 30 days after last dose, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
15.0%
3/20 • Number of events 5 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Nervous system - Other - Anomia
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Nervous system - Other - Rigors
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Investigations
Neutrophil count decreased
|
100.0%
7/7 • Number of events 26 • Up to 30 days after last dose, up to 2 years
|
66.7%
2/3 • Number of events 21 • Up to 30 days after last dose, up to 2 years
|
55.0%
11/20 • Number of events 47 • Up to 30 days after last dose, up to 2 years
|
57.9%
11/19 • Number of events 43 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Nasal dryness
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 4 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Nasal irritation
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Nervous system disorders
Restlessness
|
14.3%
1/7 • Number of events 3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Gastrointestinal disorders
Retinal Tear
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
14.3%
1/7 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Reproductive system and breast disorders
Scrotal pain
|
28.6%
2/7 • Number of events 2 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - L Ankle lesion
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - L skin lesion (Wrist)
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Petechial rash
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Purulence at site of prior picc line
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
5.0%
1/20 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/19 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - R leg nodules
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - R leg subcu nodules
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Right neck rash
|
0.00%
0/7 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/3 • Up to 30 days after last dose, up to 2 years
|
0.00%
0/20 • Up to 30 days after last dose, up to 2 years
|
5.3%
1/19 • Number of events 1 • Up to 30 days after last dose, up to 2 years
|
Additional Information
Dr. Joshua F. Zeidner
University of North Carolina, Lineberger Comprehensive Cancer Center
Phone: 919-962-5164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60