Trial Outcomes & Findings for Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer (NCT NCT03006302)
NCT ID: NCT03006302
Last Updated: 2024-10-08
Results Overview
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
9 weeks
Results posted on
2024-10-08
Participant Flow
One participant was excluded from analysis because they did not receive the study drug due to their inability to maintain eligibility after enrollment.
Participant milestones
| Measure |
Part 1: Dose Level 1
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207 Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
3
|
7
|
20
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
1
|
7
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer
Baseline characteristics by cohort
| Measure |
Part 1: Dose Level 1
n=6 Participants
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1: Dose Level 2
n=4 Participants
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 2
n=3 Participants
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
n=7 Participants
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
n=20 Participants
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
38 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
36 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: In Part 1 of the study (Epacadostat dose escalation), six patients were assessed in Dose Level 1 (DL1), seven patients were assessed in Dose Level 2 (DL2), and six patients were assessed in Dose Level 3 (DL3) since one patient was replaced because they came off treatment prior to completing the dose limiting toxicity (DLT) review period.
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
Outcome measures
| Measure |
Part 1: Dose Escalation
n=19 Participants
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Epacadostat
|
600 mg BID
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Per the clinical trial design, 6 month survival analyses included all subjects who received the MTD (Dose Level 3). Since the enrollment criteria and dose are the same, combining those who are treated at MTD at both parts increase the power and enable to estimate the treatment effect with increased precision. This included the 6 subjects evaluable in Part 1X portion of the trial and the 20 subjects enrolled in Part 2 portion of the trial for a total of 26 subjects.
Number of subjects who are alive 6 months or longer after the date of first treatment.
Outcome measures
| Measure |
Part 1: Dose Escalation
n=26 Participants
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1: Dose Level 2
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 2
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
|---|---|---|---|---|---|
|
6 Month Survival
|
12 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 monthsOutcome measures
| Measure |
Part 1: Dose Escalation
n=6 Participants
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1: Dose Level 2
n=4 Participants
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 2
n=3 Participants
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
n=7 Participants
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
n=20 Participants
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1: Dose Level 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Part 1: Dose Level 2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1X: Dose Level 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1X: Dose Level 3
Serious events: 2 serious events
Other events: 7 other events
Deaths: 7 deaths
Part 2: Dose Expansion
Serious events: 7 serious events
Other events: 20 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Part 1: Dose Level 1
n=6 participants at risk
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
|
Part 1: Dose Level 2
n=4 participants at risk
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
|
Part 1X: Dose Level 2
n=3 participants at risk
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
n=7 participants at risk
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
n=20 participants at risk
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Gastroparesis
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Disease progression
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
30.0%
6/20 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Visceral arterial ischemia
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Volume overload
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
IVC stenosis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Jejunal stenosis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Blood and lymphatic system disorders
Immune Thrombocytopenic Purpura
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Transaminitis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Fever
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Billiary track infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Stroke
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
Other adverse events
| Measure |
Part 1: Dose Level 1
n=6 participants at risk
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
|
Part 1: Dose Level 2
n=4 participants at risk
Epacadostat/Pembrolizumab/CY/GVAX/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m\^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
|
Part 1X: Dose Level 2
n=3 participants at risk
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (300 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 1X: Dose Level 3
n=7 participants at risk
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Part 2: Dose Expansion
n=20 participants at risk
Epacadostat/Pembrolizumab/CRS-207
Epacadostat: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (600 mg) is taken by mouth twice a day, every day.
Pembrolizumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207: CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10\^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
66.7%
2/3 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
35.0%
7/20 • Number of events 17 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Cold intolerance-hands and feet
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
66.7%
2/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
30.0%
6/20 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Blood and lymphatic system disorders
Enlarged lymp nodes
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 12 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
66.7%
2/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
71.4%
5/7 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
85.0%
17/20 • Number of events 47 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
66.7%
2/3 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
57.1%
4/7 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Cardiac disorders
Pseudoaneurysm
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Ear and labyrinth disorders
Ear bleading
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
42.9%
3/7 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
15.0%
3/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
42.9%
3/7 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
5/20 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Polydipsia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Pancreatic duct stricture
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
75.0%
3/4 • Number of events 12 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
75.0%
15/20 • Number of events 35 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
30.0%
6/20 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Chills
|
66.7%
4/6 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
100.0%
3/3 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
100.0%
7/7 • Number of events 17 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
95.0%
19/20 • Number of events 64 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Edema face
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Edema limbs
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
40.0%
8/20 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Fever
|
50.0%
3/6 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
100.0%
3/3 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
71.4%
5/7 • Number of events 16 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
95.0%
19/20 • Number of events 66 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Pain at biopsy site
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Groin pain
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Influenza viral infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
COVID-19-infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Thrush
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
15.0%
3/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
5/20 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
100.0%
3/3 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
57.1%
4/7 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
55.0%
11/20 • Number of events 14 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Serum amylase increased
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Weight gain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Weight loss
|
50.0%
3/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
75.0%
3/4 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
66.7%
2/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
57.1%
4/7 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
45.0%
9/20 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
30.0%
6/20 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
42.9%
3/7 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
40.0%
8/20 • Number of events 26 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Metabolism and nutrition disorders
Pain in extremity
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
15.0%
3/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
15.0%
3/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Nervous system disorders
Depression
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Reproductive system and breast disorders
Uterine obstruction
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
10.0%
2/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
20.0%
4/20 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Subungual hematoma
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
75.0%
3/4 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
28.6%
2/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
40.0%
8/20 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
15.0%
3/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
5.0%
1/20 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Infections and infestations
MRSA infection
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal mass
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin peeling
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site erythema
|
100.0%
6/6 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
75.0%
3/4 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site hyperpigmentation
|
50.0%
3/6 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site induration
|
100.0%
6/6 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
100.0%
4/4 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site pain
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
50.0%
2/4 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site pruritis
|
50.0%
3/6 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
75.0%
3/4 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Vascular disorders
IVC stenosis
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
25.0%
1/4 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
14.3%
1/7 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
0.00%
0/20 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 18 months. All-cause mortality was evaluated for up to 67 months. During the survival follow-up portion of the trial, patients were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place