Trial Outcomes & Findings for Study of INCB086550 in Select Solid Tumors (NCT NCT04629339)
NCT ID: NCT04629339
Last Updated: 2025-03-13
Results Overview
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), confirmed by ≥1 repeat assessment ≥28 days later, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
up to 733 days
Results posted on
2025-03-13
Participant Flow
This study was conducted at 10 study centers in Hungary, Korea, and Ukraine.
Participant milestones
| Measure |
NSCLC 400 mg BID
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
6
|
7
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
7
|
0
|
Reasons for withdrawal
| Measure |
NSCLC 400 mg BID
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
2
|
2
|
0
|
|
Overall Study
Disease Progression
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Study of INCB086550 in Select Solid Tumors
Baseline characteristics by cohort
| Measure |
NSCLC 400 mg BID
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 Participants
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 Participants
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 Participants
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 Participants
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: up to 733 daysPopulation: Full Analysis Set: all study participants who received ≥1 dose of study drug. Participants were analyzed according to the treatment group/dose to which they were assigned. Confidence intervals were calculated using the Clopper-Pearson method.
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), confirmed by ≥1 repeat assessment ≥28 days later, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Outcome measures
| Measure |
NSCLC 400 mg BID
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 Participants
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 Participants
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 Participants
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 Participants
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: up to 733 daysPopulation: Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method.
DCR was defined as the percentage of participants with a best overall response of CR or PR, confirmed by ≥1 repeat assessment ≥28 days later, or stable disease (SD) for ≥12 weeks, by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Progressive disease (PD): progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Outcome measures
| Measure |
NSCLC 400 mg BID
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 Participants
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 Participants
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 Participants
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 Participants
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: up to 733 daysPopulation: Full Analysis Set. Only participants with a CR or PR were analyzed.
DOR was defined as the time from the earliest date of CR or PR, confirmed by ≥1 repeat assessment ≥28 days later, until the earliest date of disease progression by investigator assessment per RECIST v1.1, or death due to any cause, if occurring sooner than progression. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Outcome measures
| Measure |
NSCLC 400 mg BID
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 Participants
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=1 Participants
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 Participants
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
3.7 months
Standard Deviation NA
Standard deviation cannot be reported for a single participant.
|
—
|
7.4 months
Standard Deviation NA
Standard deviation cannot be reported for a single participant.
|
23.7 months
Standard Deviation NA
Standard deviation cannot be reported for a single participant.
|
SECONDARY outcome
Timeframe: up to 823 daysPopulation: Safety Evaluable Population: all participants who received ≥1 dose of study drug. Treatment groups for this population were determined according to the actual treatment group/dose the participant received regardless of assigned study drug treatment.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
NSCLC 400 mg BID
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 Participants
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 Participants
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 Participants
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 Participants
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 823 daysPopulation: Safety Evaluable Population
A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
NSCLC 400 mg BID
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 Participants
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 Participants
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 Participants
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 Participants
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
|---|---|---|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
NSCLC 400 mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
UC 400 mg BID
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
RCC 400 mg BID
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Melanoma 400 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Melanoma 400 mg BID Intermittent Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Total
Serious events: 3 serious events
Other events: 14 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
NSCLC 400 mg BID
n=1 participants at risk
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 participants at risk
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 participants at risk
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 participants at risk
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 participants at risk
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Total
n=16 participants at risk
Total
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
100.0%
1/1 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
Other adverse events
| Measure |
NSCLC 400 mg BID
n=1 participants at risk
Participants with non-small cell lung cancer (NSCLC) received INCB086550 orally in 28-day cycles at a dose of 400 milligrams (mg) twice daily (BID) for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
UC 400 mg BID
n=1 participants at risk
Participants with urothelial carcinoma (UC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
RCC 400 mg BID
n=6 participants at risk
Participants with renal cell carcinoma (RC) received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID
n=7 participants at risk
Participants with melanoma received INCB086550 orally in 28-day cycles at a dose of 400 mg BID for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Melanoma 400 mg BID Intermittent Dose
n=1 participants at risk
Participants with melanoma received intermittent INCB086550 orally in 28-day cycles at a dose of 400 mg BID. Participants received INCB086550 for 1 week followed by 1 week off for up to 2 years as long as they received benefit and didn't meet any criteria for study withdrawal. Participants who achieved a complete response could have continued to receive INCB086550 for an additional 4 cycles (with a minimum of 1 year of treatment) upon medical monitor consultation.
|
Total
n=16 participants at risk
Total
|
|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
50.0%
3/6 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
25.0%
4/16 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
28.6%
2/7 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
33.3%
2/6 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Nervous system disorders
Brain compression
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
28.6%
2/7 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
18.8%
3/16 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
100.0%
1/1 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
33.3%
2/6 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
33.3%
2/6 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
28.6%
2/7 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
18.8%
3/16 • Number of events 6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
100.0%
1/1 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
100.0%
1/1 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Ligamentum flavum hypertrophy
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
33.3%
2/6 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 4 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
18.8%
3/16 • Number of events 6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
100.0%
1/1 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 3 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
14.3%
1/7 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
12.5%
2/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
100.0%
1/1 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/6 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
100.0%
1/1 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
16.7%
1/6 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/7 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
0.00%
0/1 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
6.2%
1/16 • Number of events 2 • from the time of Informed Consent Form signing until at least 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurred first (up to approximately 2.5 years)
Adverse events were assessed in members of the Safety Evaluable Population, comprised of all participants who received received ≥1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER