Trial Outcomes & Findings for Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma (NCT NCT02002598)
NCT ID: NCT02002598
Last Updated: 2024-09-19
Results Overview
MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2024-09-19
Participant Flow
23 participants signed a consent form; 2 were screen fails and 1 was removed from the study prior to the study start and did not receive the study interventions.
Participant milestones
| Measure |
Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
Participants will receive 27 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
Participants will receive 45 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
Participants will receive 56 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
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Dose Level 1
STARTED
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2
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0
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0
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0
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0
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Dose Level 1
COMPLETED
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1
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0
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0
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0
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0
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Dose Level 1
NOT COMPLETED
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1
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0
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0
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0
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Dose Level 2
STARTED
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0
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1
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0
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Dose Level 2
COMPLETED
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1
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NOT COMPLETED
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Dose Level 3
STARTED
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1
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Dose Level 3
COMPLETED
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Dose Level 3
NOT COMPLETED
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Dose Level 4
STARTED
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0
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0
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1
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Dose Level 4
COMPLETED
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0
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0
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1
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Dose Level 4
NOT COMPLETED
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Dose Level 5
STARTED
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0
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15
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Dose Level 5
COMPLETED
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0
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15
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Dose Level 5
NOT COMPLETED
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Carfilzomib 27 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
Participants will receive 27 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 36 mg/m^2, Bendamustine 70 mg/m^2, Dexamethasone 20 mg
Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 70 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 36 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
Participants will receive 36 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 45 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
Participants will receive 45 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
Carfilzomib 56 mg/m^2, Bendamustine 90 mg/m^2, Dexamethasone 20 mg
Participants will receive 56 mg/m\^2 of Carfilzomib on Days 1, 2, 8, 9, 15, \& 16 and 90 mg/m\^2 of Bendamustine by IV on days 1 \& 2 in a 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first. 20 mg Dexamethasone will be administered by PO or IV on Days 1, 2, 8, 9, 15, 16, 22, \& 23 of each 28-day cycle.
|
|---|---|---|---|---|---|
|
Dose Level 1
Withdrawal by Subject
|
1
|
0
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0
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0
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0
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Baseline Characteristics
Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
CFZ With Bendamustine and Dexamethasone
n=20 Participants
First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg.
Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: A total of 19 out of 19 participants were analyzed when evaluating the maximum tolerated dose. Participants who received dose level 5 continued to be evaluated for dose limiting toxicities.
MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=19 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone
|
56 mg/m^2
|
SECONDARY outcome
Timeframe: 2 yearsORR defined as the number of participants demonstrating complete response or partial response. Complete response defined as complete disappearance of an M-protein and no evidence of MM in the bone marrow. Partial response defined as ≥50% reduction in the level of the serum monoclonal paraprotein, reduction in 24-hour M-protein either by greater than or equal to 90% or to \<200 mg, ≥50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination), no increase in the number or size of lytic bone lesions.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=19 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Overall Response Rate (ORR)
|
19 participants
|
SECONDARY outcome
Timeframe: Up to 6.5 yearsThe TTNT is measured from the date of initiation of treatment to the start date of the next treatment regimen.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=19 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Time to Next Treatment (TTNT)
|
77.0 months
Interval 36.1 to
The upper limit is not applicable due an to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 6.5 YearsPFS is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=19 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Progression Free Survival (PFS)
|
77 Months
Interval 34.5 to
The upper limit is not applicable due an to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 2 yearsTime to the best response recorded.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=19 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Time to Best Response
|
10.23 Months
Interval 4.87 to 12.96
|
SECONDARY outcome
Timeframe: Up to 6.5 YearsThe percentage of people who are still alive.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=19 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Overall Survival (OS) Rate
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 Days Post Last Dose, Up to approximately 9 monthsTotal number of AEs observed.
Outcome measures
| Measure |
CFZ With Bendamustine and Dexamethasone
n=20 Participants
All participants who received at least two cycles of CFZ either at 27mg/m\^2, 36mg/m\^2, 45 mg/m\^2, or 56mg/m\^2.
|
|---|---|
|
Number of Adverse Events (AEs)
|
106 Adverse Events
|
Adverse Events
CFZ With Bendamustine and Dexamethasone
Serious events: 7 serious events
Other events: 20 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CFZ With Bendamustine and Dexamethasone
n=20 participants at risk
First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg.
Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorder
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Abdominal infection
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
General disorders and administration site conditions
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Infections and infestations
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Lung infection
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
Other adverse events
| Measure |
CFZ With Bendamustine and Dexamethasone
n=20 participants at risk
First participant received: CFZ 27mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Second participant received: CFZ 36mg/m\^2, Bendamustine 70mg/m\^2, Dexamethasone 20mg; Third participant received: CFZ 36mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fourth participant received: CFZ 45mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg; Fifth participant and all other participants received: CFZ 56mg/m\^2, Bendamustine 90mg/m\^2, Dexamethasone 20mg.
Data was collected and analyzed as one arm for this single-arm study. Additionally, presented as one arm to protect the confidentiality of the first four participants.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
4/19 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Psychiatric disorders
Agitation
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Blood and lymphatic system disorders
Anemia
|
65.0%
13/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Bronchial infection
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Cardiac disorders
Cardiac Disorder
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Eye disorders
Cataract
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
Chills
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Colitis
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
6/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Creatinine increased
|
35.0%
7/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
8/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Dysgeusia
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
Edema limbs
|
50.0%
10/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Eye disorders
Eye Disorder
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
Fatigue
|
25.0%
5/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
Fever
|
30.0%
6/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Eye disorders
Floaters
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
6/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Immune system disorders
Immune system disorder
|
45.0%
9/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Infections and infestation
|
30.0%
6/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Investigations - Other
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Psychiatric disorders
Libido decreased
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Lymphocyte count decreased
|
35.0%
7/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
General disorders
Malaise
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorder
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Mucosal infection
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
5/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
9/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Neutrophil count decreased
|
40.0%
8/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Non-cardiac chest pain
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Paresthesia
|
15.0%
3/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Vascular disorders
Phlebitis
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Phlebitis infective
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Platelet count decreased
|
65.0%
13/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Radiculitis
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Renal and urinary disorders
Renal and urinary disorder
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorder
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Stroke
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Vascular disorders
Thromboembolic event
|
20.0%
4/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Upper respiratory infection
|
35.0%
7/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Infections and infestations
Urinary tract infection
|
30.0%
6/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Weight gain
|
5.0%
1/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
Weight loss
|
25.0%
5/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
2/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
|
Investigations
White blood cell decreased
|
35.0%
7/20 • Serious and Other Adverse Events were monitored 30 days post last dose, up to approximately 9 months. All-Cause Mortality was assessed for up to 6.5 years.
Adverse events collected by investigator assessment on day 1 of each cycle and by laboratory assessment on days 1, 8, and 15 of each cycle.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place