Trial Outcomes & Findings for Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC) (NCT NCT03057600)
NCT ID: NCT03057600
Last Updated: 2022-09-28
Results Overview
ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessment performed no less than 4 weeks after the criteria for response were first met.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Maximum duration of follow-up for ORR was 14.8 months.
Results posted on
2022-09-28
Participant Flow
Participant milestones
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
20
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
20
|
13
|
Reasons for withdrawal
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
4
|
0
|
|
Overall Study
Radiologic Disease Progression
|
8
|
7
|
13
|
10
|
|
Overall Study
Symptomatic Deterioration
|
0
|
1
|
1
|
0
|
|
Overall Study
Investigator Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Study Termination by Sponsor
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Other, Not Specified
|
1
|
1
|
1
|
1
|
Baseline Characteristics
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
Baseline characteristics by cohort
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 Participants
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 Participants
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=20 Participants
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 Participants
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 8.68 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 13.02 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 11.13 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 11.78 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Maximum duration of follow-up for ORR was 14.8 months.Population: Response Evaluable Analysis Set: all participants who had measurable disease at baseline, received at least 1 dose of study drug (telaglenastat or paclitaxel) and completed at least 1 post baseline tumor assessment.
ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessment performed no less than 4 weeks after the criteria for response were first met.
Outcome measures
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 Participants
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 Participants
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=19 Participants
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 Participants
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
53.8 percentage of participants
Interval 25.1 to 80.8
|
SECONDARY outcome
Timeframe: Maximum duration of follow-up for PFS was 17.0 months.Population: PFS Evaluable Analysis Set: all participants who received at least 1 dose of any study-specific treatment (telaglenastat or paclitaxel).
PFS was defined as time from the first dose date to the earlier of either progression of disease per RECIST v1.1 or death from any cause. The duration of progression-free survival was censored at the date of last radiographic disease if the patient was alive and progression free at the time of analysis data cutoff, disease progression or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol TNBC treatment prior to documentation of disease progression. Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% confidence interval (CI) is used. Progressive Disease (PD) per RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 Participants
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 Participants
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=20 Participants
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 Participants
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) as Assessed by Investigator
|
2.30 months
Interval 1.74 to 3.48
|
5.49 months
Interval 1.84 to 5.72
|
2.00 months
Interval 1.64 to 3.38
|
7.33 months
Interval 3.71 to 16.46
|
SECONDARY outcome
Timeframe: Maximum duration of follow-up for OS was 24.1 months.Population: PFS Evaluable Analysis Set: all participants who received at least 1 dose of any study-specific treatment (telaglenastat or paclitaxel).
Overall survival is defined as the time from the first dose date to death due to any cause. For patients alive at time of analysis, overall survival will be censored at the time when the patient is last known to be alive.Kaplan-Meier product-limit estimates. Brookmeyer-Crowley methodology for a non-parametric 95% CI is used. Median is defined to be the smallest observed survival time for which the value of the estimated survival function is less than or equal to 0.5.
Outcome measures
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 Participants
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 Participants
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=20 Participants
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 Participants
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
7.26 months
Interval 5.09 to 16.95
|
13.47 months
Interval 6.97 to 14.69
|
6.44 months
Interval 2.73 to 8.84
|
16.76 months
Interval 12.88 to
Not estimable due to small number of events.
|
SECONDARY outcome
Timeframe: Maximum duration of follow-up for DOR was 14.8 months.Population: Response Evaluable Analysis Set: all participants who had measurable disease at baseline, received at least 1 dose of study drug (telaglenastat or paclitaxel) and completed at least 1 post baseline tumor assessment. Participants defined as responders.
Duration of response is defined as the time between the first documentation of a confirmed PR or a CR to the first documentation of PD or death, whichever occurs first. The duration of response will be censored at the date of last radiographic disease if the patient is alive and progression free at the time of database lock, disease progression or death occurs after missing data for two consecutive radiographic disease assessments, or patient receives non-protocol TNBC treatment prior to documentation of disease progression. RECIST v1.1 criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=2 Participants
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=1 Participants
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=2 Participants
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=7 Participants
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 3.68 to
Not Estimable. Among the 2 participants analyzed, 1 participant was censored for duration of response. Median and upper bound of 95% confidence interval could not be estimated based on uncensored data from 1 participant.
|
6.47 months
95% confidence interval not calculable because data were only collected for 1 participant.
|
7.61 months
Interval 4.07 to 11.14
|
11.04 months
Interval 5.55 to 14.75
|
SECONDARY outcome
Timeframe: Maximum duration of follow-up for CBR was 14.8 months.Population: Response Evaluable Analysis Set: all participants who had measurable disease at baseline, received at least 1 dose of study drug (telaglenastat or paclitaxel) and completed at least 1 post baseline tumor assessment.
Clinical Benefit Rate is defined as the percentage of patients with best response of CR, PR, or SD per RECIST v1.1 criteria lasting ≥ 16 weeks for 3rd line + patients and ≥ 24 weeks for 1st line patients. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 Participants
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets orally (PO) twice daily (BID) on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 Participants
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=19 Participants
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 Participants
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
61.5 percentage of participants
Interval 31.6 to 86.1
|
Adverse Events
Cohort 1 - African Ancestry, 3rd Line+
Serious events: 2 serious events
Other events: 9 other events
Deaths: 7 deaths
Cohort 2 - African Ancestry, 1st Line
Serious events: 2 serious events
Other events: 10 other events
Deaths: 7 deaths
Cohort 3 - Non-African Ancestry, 3rd Line+
Serious events: 5 serious events
Other events: 19 other events
Deaths: 14 deaths
Cohort 4 - Non-African Ancestry, 1st Line
Serious events: 2 serious events
Other events: 13 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 participants at risk
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 participants at risk
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=20 participants at risk
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 participants at risk
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Cardiac disorders
Pericardial effusion
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Septic shock
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
Other adverse events
| Measure |
Cohort 1 - African Ancestry, 3rd Line+
n=9 participants at risk
Participants self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 2 - African Ancestry, 1st Line
n=10 participants at risk
Participants self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 3 - Non-African Ancestry, 3rd Line+
n=20 participants at risk
Participants not self-identifying as African ancestry (includes African American) with at least 2 prior lines of systemic therapy for advanced/metastatic disease including a taxane, received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
Cohort 4 - Non-African Ancestry, 1st Line
n=13 participants at risk
Participants not self-identifying as African ancestry (includes African American) with no prior systemic therapy for advanced or metastatic disease received 800 mg CB-839 tablets PO BID on Days 1 through 28 of each 28-day cycle along with 80 mg/m\^2 of paclitaxel IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression, unacceptable toxicity, initiation of another systemic anticancer treatment, death, or withdrawal of consent.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
55.6%
5/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.0%
3/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
50.0%
10/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
76.9%
10/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Oedema peripheral
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Chest pain
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Chills
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
23.1%
3/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Mucosal inflammation
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Oedema
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Peripheral swelling
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Asthenia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Axillary pain
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Chest discomfort
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Generalised oedema
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Localised oedema
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
General disorders
Swelling
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
40.0%
8/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
50.0%
5/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
25.0%
5/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
38.5%
5/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
25.0%
5/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Oral herpes
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Neuropathy peripheral
|
44.4%
4/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
38.5%
5/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.0%
6/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Balance disorder
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Jugular vein occlusion
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
40.0%
4/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
35.0%
7/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.0%
6/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
40.0%
4/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
25.0%
5/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
40.0%
4/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
4/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
38.5%
5/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
38.5%
5/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
White blood cell count decreased
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.0%
3/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
23.1%
3/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Weight decreased
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Electrocardiogram QT prolonged
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Investigations
Weight increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
4/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
38.5%
5/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
23.1%
3/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.0%
3/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Injury, poisoning and procedural complications
Fracture
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.0%
3/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
4/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
23.1%
3/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Gastrointestinal disorders
Cheilitis
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Skin and subcutaneous tissue disorders
Scratch
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
40.0%
4/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
25.0%
5/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.8%
4/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
23.1%
3/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Bacterial vaginosis
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Photophobia
|
22.2%
2/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
4/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Vision blurred
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Vitreous floaters
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Dry eye
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Cataract
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Eye disorder
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
30.0%
3/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
15.4%
2/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
20.0%
2/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Vascular disorders
Lymphoedema
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
2/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
5.0%
1/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Reproductive system and breast disorders
Breast pain
|
11.1%
1/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Infections and infestations
Mastitis
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
10.0%
1/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/9 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/10 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
0.00%
0/20 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
7.7%
1/13 • All Cause Mortality: from enrollment through study follow-up. Maximum duration of follow-up was 24.1 months. Adverse Events: from first dose of study drug through end of treatment (EOT) + 28 days post treatment discontinuation. Median duration of treatment was 84 days for COhort 1, 118 days for Cohort 2, 51.0 days for Cohort 3, and 224.0 days for Cohort 4.
Per protocol, Grade 5 disease progression events are excluded from these tables. Disease progression includes events in the preferred terms of disease progression and malignant neoplasm progression.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication by the PI before either a multi-site publication or 18 months after final multi-site study report. PI can only publish their own results and provide 45 days in advance notice. PI must delete any Calithera confidential information from the publication other than study results and give good faith consideration to other comments made by Calithera. The PI must delay the publication for up to 45 days if requested by Calithera and publicly acknowledge Calithera and Pfizer support.
- Publication restrictions are in place
Restriction type: OTHER