Trial Outcomes & Findings for Vyxeos for Induction of Low- or Intermediate-risk. (NCT NCT05599360)

Last Updated: 2026-09-03

Results Overview

To assess the response rate for low/intermediate risk AML after induction with Vyxeos with or without Mylotarg, including complete remission (CR) and complete remission with incomplete hematologic recovery (CRi).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

up to 1 month

Results posted on

2026-09-03

Participant Flow

Patients were assigned for a specific arm as per physician decision. There was no randomization.

Participant milestones

Participant milestones
Measure	Vyxeos With Mylotarg Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care. Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.	Vyxeos Without Mylotarg Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care.
Overall Study STARTED	6	14
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	4	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vyxeos for Induction of Low- or Intermediate-risk.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vyxeos With Mylotarg. n=6 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.	Vyxeos Without Mylotarg. n=14 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=136 Participants	9 Participants n=136 Participants	15 Participants n=272 Participants
Age, Categorical >=65 years	0 Participants n=136 Participants	5 Participants n=136 Participants	5 Participants n=272 Participants
Sex: Female, Male Female	0 Participants n=136 Participants	10 Participants n=136 Participants	10 Participants n=272 Participants
Sex: Female, Male Male	6 Participants n=136 Participants	4 Participants n=136 Participants	10 Participants n=272 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=136 Participants	11 Participants n=136 Participants	16 Participants n=272 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=136 Participants	3 Participants n=136 Participants	4 Participants n=272 Participants
Region of Enrollment Israel	6 participants n=136 Participants	14 participants n=136 Participants	20 participants n=272 Participants

PRIMARY outcome

Timeframe: up to 1 month

Population: 1. Patients treated with Vyxeos without Mylotarg. 2. Patients treated with Vyxeos, with Mylotarg.

Outcome measures

Outcome measures
Measure	Vyxeos Without Mylotarg n=14 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care.	Vyxeos With Mylotarg n=6 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care. Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.
Response Rate for Low/Intermediate Risk Acute Myeloid Leukemia (AML) After Induction With Vyxeos With or Without Mylotarg.	13 Participants	6 Participants

PRIMARY outcome

Timeframe: 1 month

Comparison between Grade 3-4 AEs of patient that was given the combination of the CPX-351 plus Mylotarg and AEs of patients that was given CPX-351 only.

Outcome measures

Outcome measures
Measure	Vyxeos Without Mylotarg n=6 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care.	Vyxeos With Mylotarg n=14 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care. Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.
Safety of the CPX-351 and GO (Mylotarg) Combination	6 Participants	12 Participants

SECONDARY outcome

Timeframe: 1 month

MFC MRD-Negative post CPX-351 ± Mylotarg induction therapy.

Outcome measures

Outcome measures
Measure	Vyxeos Without Mylotarg n=6 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care.	Vyxeos With Mylotarg n=14 Participants Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care. Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.
MRD Evaluation	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 5 years

Overall survival is defined as the time from diagnosis to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Disease-free survival defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease or death.

Outcome measures

Outcome data not reported

Adverse Events

Vyxeos With Mylotarg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Vyxeos Without Mylotarg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vyxeos With Mylotarg n=6 participants at risk Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care. Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.	Vyxeos Without Mylotarg n=14 participants at risk Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection
Infections and infestations Sepsis	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.

Other adverse events

Additional Information

Dr. Chezi Ganzel

Hematology and Bone Marrow Transplantation Department, the Eisenberg R&D Authority, Shaare Zedek Medical Center, and Faculty of Medicine, Hebrew University, Jerusalem, Israel

Phone: 972-2-6555231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee SITE and/or Investigator may not publish any publication in regard of the Study without SZMC written approval. In any publication or presentation of the Study, SITE will give full acknowledgement to SZMC and Dr. Chezi Ganzel.
Publication restrictions are in place

Restriction type: OTHER

Measure	Vyxeos With Mylotarg n=6 participants at risk Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection Vyxeos with or without Mylotarg as per physician decision since Mylotarg is used sometimes and standard of care. Mylotarg: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.	Vyxeos Without Mylotarg n=14 participants at risk Vyxeos: Vyxeos (daunorubicin and cytarabine) liposome for injection
General disorders Weight gain	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Febrile neutropenia	66.7% 4/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	50.0% 7/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Transfusion reaction	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Blood and lymphatic system disorders DVT	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Blood and lymphatic system disorders Epistaxis	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Blood and lymphatic system disorders SVT	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Cardiac disorders Tachycardia	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Chills	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Edema/fluid retention	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	50.0% 7/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Fatigue	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Fever	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	42.9% 6/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
General disorders Pain- abdominal /pelvic	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Constipation	66.7% 4/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	71.4% 10/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Diarrhea	66.7% 4/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Heartburn/ reflux	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Hemorrhoids	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Nausea	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	35.7% 5/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Blood and lymphatic system disorders Neutropenia	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	57.1% 8/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 3/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	71.4% 10/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Blood and lymphatic system disorders Anemia	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	28.6% 4/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Infections and infestations Cellulitis	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Infections and infestations Herpes	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	42.9% 6/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Infections and infestations Phlebitis	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Hepatobiliary disorders ALK Phos- elevated	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Hepatobiliary disorders ALT- elevated	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Hepatobiliary disorders AST - elevated	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Hepatobiliary disorders Abnormal liver enzymes	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	71.4% 10/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Metabolism and nutrition disorders Hyperphosphatemia	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	35.7% 5/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Nervous system disorders Anxiety	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Nervous system disorders Dizziness	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Nervous system disorders Headache	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	28.6% 4/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Nervous system disorders Insomnia	33.3% 2/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Oral mucositis	50.0% 3/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Sore Throat	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Gastrointestinal disorders Teeth/ dental pain	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	7.1% 1/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Skin and subcutaneous tissue disorders Furuncles	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	14.3% 2/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Skin and subcutaneous tissue disorders Itching	0.00% 0/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	21.4% 3/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.
Skin and subcutaneous tissue disorders Rash/ skin redness	100.0% 6/6 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.	35.7% 5/14 • All adverse events (AEs) will be collected from screening date through 30 days after the last dose, up to a total of 40 days.