Trial Outcomes & Findings for CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old (NCT NCT04269213)
NCT ID: NCT04269213
Last Updated: 2026-08-31
Results Overview
Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
At day 45
Results posted on
2026-08-31
Participant Flow
Participant milestones
| Measure |
Treatment (CPX-351)
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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
Baseline characteristics by cohort
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 13.00 • n=14 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: At day 45Population: 19 patients were evaluable for the disease response.
Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.
Outcome measures
| Measure |
Treatment (CPX-351)
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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Complete Response Rate (Morphological Complete Remission [CR] and Incomplete Blood Count Recovery [CRi])
|
8 Participants
|
SECONDARY outcome
Timeframe: Time from overall CR or CRi until relapse or last follow-up, assessed up to 50 monthsPopulation: 10 patients achieved overall CR or CRi and can be included in this analysis.
Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Outcome measures
| Measure |
Treatment (CPX-351)
n=10 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
CR + CRi Duration
|
11 months
Interval 0.8 to
90% Confidence Interval was not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 50 monthsWill be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Outcome measures
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Event Free Survival
|
8.5 Months
Interval 0.7 to
Upper limit of 90% Confidence Interval was not reached due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Time from treatment until death due to any cause or last follow-up, assessed up to 50 monthsWill be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.
Outcome measures
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Overall Survival
|
12.3 months
Interval 6.2 to 19.3
|
SECONDARY outcome
Timeframe: Up to 50 monthsTransplant rate estimated using a 90% confidence interval obtained using Jeffrey's prior method.
Outcome measures
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Allogeneic Hematopoietic Cell Transplant (HSCT) Rate
|
12 participants
|
SECONDARY outcome
Timeframe: Up to 50 monthsWill report Incidence of adverse events with highest maximum grade seen using frequencies and relative frequencies.
Outcome measures
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Incidence of Adverse Events
Highest Maximum Grade Seen: Grade 1
|
0 Participants
|
|
Incidence of Adverse Events
Highest Maximum Grade Seen: Grade 2
|
1 Participants
|
|
Incidence of Adverse Events
Highest Maximum Grade Seen: Grade 3
|
8 Participants
|
|
Incidence of Adverse Events
Highest Maximum Grade Seen: Grade 4
|
11 Participants
|
|
Incidence of Adverse Events
Highest Maximum Grade Seen: Grade 5
|
1 Participants
|
Adverse Events
Treatment (CPX-351)
Serious events: 10 serious events
Other events: 20 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
3/21 • Number of events 3 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
General disorders
Fever
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Lung infection
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Sepsis
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Skin infection
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Vascular disorders
Thromboembolic event
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
Other adverse events
| Measure |
Treatment (CPX-351)
n=21 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.
RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.8%
5/21 • Number of events 5 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
57.1%
12/21 • Number of events 12 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Cardiac disorders
Pericarditis
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Eye disorders
Scleral disorder
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Colitis
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Diarrhea
|
23.8%
5/21 • Number of events 5 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Mucositis oral
|
23.8%
5/21 • Number of events 5 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
7/21 • Number of events 7 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Proctitis
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Rectal pain
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Number of events 3 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
General disorders
Chills
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
General disorders
Edema limbs
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
General disorders
Fatigue
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Bacteremia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Bronchial infection
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Enterocolitis infectious
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Herpes simplex reactivation
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Skin infection
|
19.0%
4/21 • Number of events 4 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Infections and infestations
Tooth infection
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Creatinine increased
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Ejection fraction decreased
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Neutrophil count decreased
|
38.1%
8/21 • Number of events 8 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Platelet count decreased
|
42.9%
9/21 • Number of events 9 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Investigations
Weight loss
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Nervous system disorders
Dysgeusia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.8%
5/21 • Number of events 5 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.5%
2/21 • Number of events 2 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
|
Vascular disorders
Hematoma
|
4.8%
1/21 • Number of events 1 • Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. AEs will be reported starting the start date of intervention through study completion, up to 50months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place