Trial Outcomes & Findings for BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NCT NCT03496662)
NCT ID: NCT03496662
Last Updated: 2025-07-29
Results Overview
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Through 100 days after completion of treatment (approximately 7.5 months)
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Part A - Experimental Dose Level 0
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
25
|
|
Overall Study
COMPLETED
|
6
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
9
|
Reasons for withdrawal
| Measure |
Part A - Experimental Dose Level 0
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
2
|
|
Overall Study
Noncompliance
|
0
|
0
|
1
|
Baseline Characteristics
BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Baseline characteristics by cohort
| Measure |
Part A - Experimental Dose Level 0
n=7 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
n=8 Participants
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=25 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.5 years
n=39 Participants
|
72 years
n=41 Participants
|
68 years
n=35 Participants
|
70 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
40 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=39 Participants
|
8 participants
n=41 Participants
|
25 participants
n=35 Participants
|
40 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Through 100 days after completion of treatment (approximately 7.5 months)Population: -Only participants enrolled in Part A- Experimental Dose Level 0 are evaluable for this outcome measure.
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Part A - Experimental Dose Level 0
n=7 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 anorexia
|
5 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 dehydration
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hyperglycemia
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 hyperglycemia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 anemia
|
6 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 anemia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 leukocytosis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 abdominal pain
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 constipation
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 diarrhea
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 diarrhea
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hemorrhoids
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 mucositis oral
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 nausea
|
6 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 4 upper gastrointestinal hemorrhage
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 vomiting
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 chills
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 edema limbs
|
5 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 fatigue
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 fatigue
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 fever
|
4 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 foot pain
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 sweating
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 activated partial thromboplastin time prolonged
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 alanine aminotransferase increased
|
4 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 alanine aminotransferase increased
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 alkaline phosphatase increased
|
4 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 alkaline phosphatase increased
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 aspartate aminotransferase increased
|
4 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 aspartate aminotransferase increased
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hypoalbuminemia
|
5 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hypocalcemia
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hypoglycemia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 creatinine increased
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 lymphocyte count decreased
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 lymphocyte count decreased
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 neutrophil count decreased
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 neutrophil count decreased
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 4 neutrophil count decreased
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 platelet count decreased
|
7 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 white blood cell decreased
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 white blood cell decreased
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hypokalemia
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 hypokalemia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hyponatremia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 hyponatremia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 arthralgia
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 back pain
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 myalgia
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 pain in extremity
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 vertigo
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 dizziness
|
4 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 dysgeusia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 headache
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 paresthesia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 peripheral sensory neuropathy
|
5 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 tremor
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 depression
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 insomnia
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 cough
|
5 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 dyspnea
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 dyspnea
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 epistaxis
|
4 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hoarseness
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 nasal congestion
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 pneumonitis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 alopecia
|
7 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 dermatitis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 discoloration
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 nail ridging
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 pruritis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 rash maculopapular
|
3 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 skin hyperpigmentation
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 acute kidney injury
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 dysuria
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hematuria
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 proteinuria
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 cholangitis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 cholecystitis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 gallbladder obstruction
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hypertension
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 hypertension
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 hypotension
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 thromboembolic event
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 chest swelling
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 sinus bradycardia
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 vaginal bleeding
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 bruising
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 infusion related reaction
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 wound dehiscence
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 3 sepsis
|
1 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 gallbladder infection
|
2 Participants
|
—
|
—
|
|
(Part A Experimental Dose Level 0 Only) Safety of the Combination of BMS-813160 Plus Nivolumab Plus Gemcitabine Plus Nab-paclitaxel as Measured by Frequency, Type, and Severity of Adverse Events
Grade 1-2 upper respiratory infection
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Through completion of treatment (approximately 4 months)Population: Part A - Control participants are not evaluable for this outcome measure. 1 participant enrolled in Part A - Experimental Dose Level 0 is not evaluable for this outcome measure as the participant withdrew prior to the imaging scan. 2 participants enrolled in Part B - Dose expansion were not evaluable for this outcome measure as 1 participant withdrew prior to the imaging scan and 1 participant died prior to the imaging scan.
* Objective response rate (ORR) is defined as number of participants with complete response or partial response. * Complete Response (CR): Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Normalization of tumor marker level. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part A - Experimental Dose Level 0
n=6 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=23 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
(Part B and Part A Experimental Dose Level 0 Only): Objective Response Rate
|
1 Participants
|
—
|
6 Participants
|
SECONDARY outcome
Timeframe: Completion of treatment (approximately 4 months)Population: Only participants enrolled to Part A - Experimental Dose Level 0 and Part B - Dose expansion were evaluable for this outcome measure.
Outcome measures
| Measure |
Part A - Experimental Dose Level 0
n=7 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=25 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
(Part B and Part A Experimental Dose Level 0 Only): Percentage of Patients Whose Disease Becomes Resectable After Treatment
|
2 Participants
|
—
|
11 Participants
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median length of follow-up 12.15 months, full range 0.43-44.10 months)Population: Participants in Part A - control were not evaluable for this outcome measure.
* PFS is defined as the days from the date of treatment and death or progression, which occurs first. Patients alive without progression or lost to follow-up are censored at the last follow-up. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Part A - Experimental Dose Level 0
n=7 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=25 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
(Part B and Part A Experimental Dose Level 0 Only): Progression-free Survival (PFS)
|
13.69 months
Interval 4.13 to 35.77
|
—
|
14.00 months
Interval 0.43 to 44.1
|
SECONDARY outcome
Timeframe: Through completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months)Population: Participants in Part A - control were not evaluable for this outcome measure.
OS is defined as days from date of treatment to date of death. Patients alive or lost to follow-up are censored at the last follow-up.
Outcome measures
| Measure |
Part A - Experimental Dose Level 0
n=7 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=25 Participants
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
(Part B and Part A Experimental Dose Level 0 Only): Overall Survival (OS)
|
22.55 months
Interval 6.37 to 64.47
|
—
|
20.39 months
Interval 0.43 to 52.43
|
Adverse Events
Part A - Experimental Dose Level 0
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
Part A - Control (Chemotherapy Only)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 4 deaths
Part B - Dose Expansion
Serious events: 17 serious events
Other events: 25 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Part A - Experimental Dose Level 0
n=7 participants at risk
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
n=8 participants at risk
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=25 participants at risk
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Cardiac disorders
Coronary vasospasm
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Fever
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Pain
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Bacteremia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Lung infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Wound infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to pancreatic adenocarcinoma
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Stroke
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
Other adverse events
| Measure |
Part A - Experimental Dose Level 0
n=7 participants at risk
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute intravenous (IV) infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part A - Control (Chemotherapy Only)
n=8 participants at risk
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
Part B - Dose Expansion
n=25 participants at risk
* BMS-813160 300 mg twice per day
* Nivolumab 30-minute IV infusion at a flat dose of 480 mg on Day 1 of each 28-day cycle
* Gemcitabine 30-minute IV infusion 1000 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Nab-paclitaxel 30-40-minute IV infusion 125 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle
* Post-treatment biopsy at the end of cycle 2
* Patients who achieve stable disease, a partial response, or complete response after the first 2 cycles of treatment will continue to receive 2 more cycles of treatment followed by a restaging scan. Patients thought to have pseudo-progression will continue to receive treatment for 2 more cycles
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
7/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
100.0%
25/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Cardiac disorders
Chest swelling
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Cardiac disorders
Prolonged QRS
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Cardiac disorders
Sinus bradycardia
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Eye disorders
Blurred vision
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
28.0%
7/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
44.0%
11/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
56.0%
14/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
24.0%
6/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Generalized edema
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
20.0%
5/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
60.0%
15/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
36.0%
9/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Body aches
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Chills
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
32.0%
8/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Dry mouth
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Edema limbs
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
48.0%
12/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Edema trunk
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Fall
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Fatigue
|
85.7%
6/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
80.0%
20/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Fever
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
40.0%
10/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Foot pain
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Hand pain
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Leg pain
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
General disorders
Sweating
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Hepatobiliary disorders
Cholangitis
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Gallbladder infection
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Sepsis
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Thrush
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Alanine aminotransferase increased
|
85.7%
6/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
68.0%
17/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Alkaline phosphatase increased
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
48.0%
12/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Aspartate aminotransferase increased
|
85.7%
6/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
56.0%
14/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Creatinine increased
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Hemoglobin increased
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Lymphocyte count decreased
|
57.1%
4/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
48.0%
12/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Neutrophil count decreased
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
44.0%
11/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Platelet count decreased
|
100.0%
7/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
72.0%
18/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
Weight loss
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Investigations
White blood cell decreased
|
85.7%
6/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
68.0%
17/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
48.0%
12/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
32.0%
8/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.1%
4/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
16.0%
4/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
92.0%
23/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
28.0%
7/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
57.1%
4/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
16.0%
4/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
48.0%
12/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
20.0%
5/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
16.0%
4/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Musculoskeletal and connective tissue disorders
Port pain
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Musculoskeletal and connective tissue disorders
Spine pain
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Dizziness
|
57.1%
4/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
32.0%
8/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
40.0%
10/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Pain in extremity
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
52.0%
13/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Nervous system disorders
Tremor
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
37.5%
3/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
20.0%
5/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Dysuria
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Hematuria
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Renal hypertension
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
71.4%
5/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
25.0%
2/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
28.0%
7/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dry nose
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
20.0%
5/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
57.1%
4/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
7/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
50.0%
4/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
72.0%
18/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
16.0%
4/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Follicular rash
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
28.0%
7/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Nail fungus
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
16.0%
4/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Pseudocellulittis
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
28.0%
7/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
56.0%
14/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.5%
1/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
4.0%
1/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Hot flashes
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Hypertension
|
42.9%
3/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Hypotension
|
28.6%
2/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
QT corrected interval prolonged
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
8.0%
2/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Thromboembolic event
|
14.3%
1/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
|
Vascular disorders
Thromboembolic event (DVT)
|
0.00%
0/7 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
0.00%
0/8 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
12.0%
3/25 • Adverse events were collected until the date of surgery, or 100 days after the last dose of treatment on study if patients did not have surgery [median treatment length was 112 days (full range 14-161 days). All-cause mortality data was collected until completion of follow-up (median length of follow-up 17.63 months, full range 0.43-64.47 months).
|
Additional Information
Kian-Huat Lim, M.D., Ph.D.
Washington University School of Medicine
Phone: 314-362-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place