Trial Outcomes & Findings for Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma (NCT NCT04979442)
NCT ID: NCT04979442
Last Updated: 2025-01-14
Results Overview
PFS is defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression, or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
175 participants
Primary outcome timeframe
from the randomization date to date of documented progression or death, up to 13 months
Results posted on
2025-01-14
Participant Flow
A total of 86 subjects were enrolled to the Milademetan arm and a total of 89 subjects were enrolled to the Trabectedin arm. Of the 89 subjects in the trabectedin arm, 79 subjects were treated.
Participant milestones
| Measure |
Milademetan
Milademetan was supplied as 30- and 100-mg strength capsules. The starting dose of milademetan 260 mg administered once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle.
|
Trabectedin
Trabectedin was provided as a sterilized lyophilized powder in single, 1-mg dose vials. Trabectedin was administered per the manufacturer's instructions at 1.5 mg/m2 body surface area (BSA) as a 24-hour IV infusion, every 3 weeks (ie, 21-day cycles) through a central venous line.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
89
|
|
Overall Study
Received Treatment
|
86
|
79
|
|
Overall Study
COMPLETED
|
34
|
42
|
|
Overall Study
NOT COMPLETED
|
52
|
47
|
Reasons for withdrawal
| Measure |
Milademetan
Milademetan was supplied as 30- and 100-mg strength capsules. The starting dose of milademetan 260 mg administered once daily (QD) orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle.
|
Trabectedin
Trabectedin was provided as a sterilized lyophilized powder in single, 1-mg dose vials. Trabectedin was administered per the manufacturer's instructions at 1.5 mg/m2 body surface area (BSA) as a 24-hour IV infusion, every 3 weeks (ie, 21-day cycles) through a central venous line.
|
|---|---|---|
|
Overall Study
Death
|
43
|
30
|
|
Overall Study
Withdrawal by Subject
|
8
|
13
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
do not want to continue
|
0
|
1
|
Baseline Characteristics
Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
Baseline characteristics by cohort
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=89 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 13.08 • n=99 Participants
|
61.8 years
STANDARD_DEVIATION 11.92 • n=107 Participants
|
60.6 years
STANDARD_DEVIATION 12.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
59 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region
North America
|
27 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Region
Europe
|
47 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Region
Rest of World
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: from the randomization date to date of documented progression or death, up to 13 monthsPopulation: Analysis population included all the randomized participants up to up to final analysis cut-off date (01 March 2023).
PFS is defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression, or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=89 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Compare Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) Between the Milademetan Treatment Arm and Trabectedin Control Arm
|
3.6 months
Interval 2.1 to 4.1
|
2.2 months
Interval 1.9 to 4.2
|
SECONDARY outcome
Timeframe: From randomization date to death. The result is based on primary analysis data cut.Population: Analysis population included all the randomized participants up to up to final analysis cut-off date (01 March 2023).
OS as measured from the date of randomization to date of death by any cause
Outcome measures
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=89 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Overall Survival (OS)
|
9.5 months
Interval 6.5 to 12.8
|
10.2 months
Interval 8.6 to
Upper limit of the 95% confidence interval not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From the randomization date to first CR, PR or SD >= 16 weeks or the primary study completion date; up to 26.6 months.DCR defined as the percentage of patients who have achieved CR, PR, or SD for \>= 16 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=89 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Disease Control Rate (DCR)
|
33.7 percentage of participants
Interval 23.9 to 44.7
|
27.0 percentage of participants
Interval 18.1 to 37.4
|
SECONDARY outcome
Timeframe: From randomization date to the first confirmed complete or partial response, or study completion date; up to 26.6 months.Population: This analysis is conducted in all participants within the Intent to treat (IIT) population
ORR defined as the percentage of patients who have achieved a confirmed CR, PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=89 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Objective Response Rate (ORR)
|
4.7 percentage of participants
Interval 1.3 to 11.5
|
3.4 percentage of participants
Interval 0.7 to 9.5
|
SECONDARY outcome
Timeframe: disease progression or deathPopulation: PFS defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, based on Investigator assessments
PFS defined as the time from randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, based on Investigator assessments
Outcome measures
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=89 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
PFS by Investigator Assessments
|
3.7 months
Interval 2.1 to 5.4
|
2.1 months
Interval 1.9 to 3.9
|
SECONDARY outcome
Timeframe: From first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.Population: All AEs were collected from the initiation of study treatment until 30 days after the last administration study drug or until initiation of another anticancer therapy, whichever came first.
All AEs were collected from the initiation of study treatment until 30 days after the last administration study drug or until initiation of another anticancer therapy, whichever came first; up to 26.6 months.
Outcome measures
| Measure |
Milademetan
n=86 Participants
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=79 Participants
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Until Approximately 30 Days After the Last Study Drug
|
86 Participants
|
78 Participants
|
Adverse Events
Milademetan
Serious events: 31 serious events
Other events: 86 other events
Deaths: 43 deaths
Trabectedin
Serious events: 38 serious events
Other events: 78 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Milademetan
n=86 participants at risk
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=79 participants at risk
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.3%
14/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
19.0%
15/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
8/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Infections and infestations
Sepsis
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
1.3%
1/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
platelet count decreased
|
3.5%
3/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
3/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
1.3%
1/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
1.3%
1/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Fatigue
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
Other adverse events
| Measure |
Milademetan
n=86 participants at risk
milademetan 260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
|
Trabectedin
n=79 participants at risk
trabectedin 1.5 mg/m2 body surface area as a 24-hour IV infusion, every 3 weeks
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
11.4%
9/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
5/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
13.9%
11/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Edema peripheral
|
4.7%
4/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
11.4%
9/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Blood creatinine increased
|
9.3%
8/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
8.9%
7/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Nervous system disorders
Headache
|
8.1%
7/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
6/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
5/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.8%
5/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
2.5%
2/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.7%
4/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Infections and infestations
COVID-19
|
8.1%
7/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
7.6%
6/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.8%
5/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
3.8%
3/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
3/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Pyrexia
|
3.5%
3/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
7.6%
6/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Weight decreased
|
3.5%
3/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Chills
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
7.6%
6/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Nausea
|
70.9%
61/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
58.2%
46/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Blood and lymphatic system disorders
Anemia
|
44.2%
38/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
36.7%
29/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Vomiting
|
44.2%
38/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
19.0%
15/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.0%
31/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
13.9%
11/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Fatigue
|
34.9%
30/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
32.9%
26/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Asthenia
|
32.6%
28/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
24.1%
19/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.1%
25/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
21.5%
17/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Diarrhea
|
27.9%
24/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
26.6%
21/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
platelet count decreased
|
25.6%
22/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
11.4%
9/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Neutrophil count decreased
|
24.4%
21/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
19.0%
15/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
18.6%
16/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
12.7%
10/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.4%
15/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
17.7%
14/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Constipation
|
11.6%
10/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
25.3%
20/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
White blood cell count decreased
|
14.0%
12/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
10.1%
8/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
4/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
25.3%
20/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Blood alkaline phosphatase increased
|
4.7%
4/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
15.2%
12/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
16.5%
13/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
7.6%
6/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Mucosal inflammation
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Myalgia
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Infections and infestations
Urinary tract infection
|
2.3%
2/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.2%
1/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Stomatitis
|
1.2%
1/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Gamma-glutamyl transferase increased
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
8.9%
7/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
General disorders
Pain
|
0.00%
0/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
5.1%
4/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Investigations
Lymphocyte count decreased
|
3.5%
3/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
6.3%
5/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
|
Gastrointestinal disorders
Dysgeusia
|
10.5%
9/86 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
7.6%
6/79 • From the first dose date to 30 days after the last dose date or the primary study completion date whichever came first; up to 26.6 months.
All-cause mortality assessed for all enrolled participants, serious and other adverse events assessed for safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place