Trial Outcomes & Findings for Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma (NCT NCT01394939)
NCT ID: NCT01394939
Last Updated: 2026-08-05
Results Overview
Percentage of participants with overall response (CR+PR) during the study per mRECIST 1.1. CR: disappearance of enhancing area; PR: \>=30% decrease in sum of enhancing area diameters. Per mRECIST 1.1, an objective response at week 8 must be confirmed by a subsequent scan to be classified as an overall response during the study. If a participant achieved a response at week 8, but the response was not confirmed at the subsequent visit, then the participant may be included in the 'ORR at Week 8 (CR+PR)' Row, but may not be included in the 'ORR During the study (CR+PR)' Row.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Scans every 8 weeks until progression, assessed up to 25 months
Results posted on
2026-08-05
Participant Flow
Of the 66 patients screened, 52 patients were enrolled into the study. For the ITT Population, 3 patients were enrolled in Cohort 1, 24 patients were enrolled in Cohort 2, 5 patients were enrolled in Cohort 3, and 20 patients were enrolled in Cohort 4 (Pexa-Vec 1 x 109 pfu + irinotecan). Two patients (1 patient each in Cohorts 2 and 4) had pre-dosing AEs that led to discontinuation from the study prior to receiving treatment and were therefore excluded from the safety population and the PPP.
Participant milestones
| Measure |
Single Agent_ Cohort 1
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 1: JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
Irinotecan: 180 mg/m2 IV every 2 weeks.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
24
|
5
|
20
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
3
|
24
|
5
|
20
|
|
Overall Study
Safety Population
|
4
|
25
|
4
|
17
|
|
Overall Study
Per Protocol Population (PPP)
|
3
|
23
|
5
|
19
|
|
Overall Study
Evaluable Patient Population (EPP)
|
3
|
21
|
4
|
17
|
|
Overall Study
Radiographic Evaluable Patient Population (REPP)
|
3
|
15
|
3
|
16
|
|
Overall Study
COMPLETED
|
3
|
15
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
1
|
10
|
Reasons for withdrawal
| Measure |
Single Agent_ Cohort 1
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 1: JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
Irinotecan: 180 mg/m2 IV every 2 weeks.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
4
|
|
Overall Study
Death
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Others
|
0
|
2
|
0
|
3
|
Baseline Characteristics
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
Baseline characteristics by cohort
| Measure |
Single Agent_ Cohort 1
n=4 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594 3 x 10\^8 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 8.06 • n=20 Participants
|
58.3 years
STANDARD_DEVIATION 11.84 • n=20 Participants
|
58.8 years
STANDARD_DEVIATION 13.74 • n=40 Participants
|
58.6 years
STANDARD_DEVIATION 10.42 • n=6 Participants
|
58.9 years
STANDARD_DEVIATION 11.05 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
20 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
44 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
48 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Scans every 8 weeks until progression, assessed up to 25 monthsPopulation: The Intent to Treat (ITT) Population comprised of all patients deemed eligible, who signed the ICF, and were enrolled in the study. For the ITT Population analyses, patients were counted under the treatment arm to which they were enrolled, regardless of treatment received. The ITT Population was the primary population for efficacy analyses.
Percentage of participants with overall response (CR+PR) during the study per mRECIST 1.1. CR: disappearance of enhancing area; PR: \>=30% decrease in sum of enhancing area diameters. Per mRECIST 1.1, an objective response at week 8 must be confirmed by a subsequent scan to be classified as an overall response during the study. If a participant achieved a response at week 8, but the response was not confirmed at the subsequent visit, then the participant may be included in the 'ORR at Week 8 (CR+PR)' Row, but may not be included in the 'ORR During the study (CR+PR)' Row.
Outcome measures
| Measure |
Single Agent_ Cohort 1
n=3 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10\^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=24 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=5 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=20 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
ORR at Week 8 (CR+PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study
ORR During the study (CR+PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: CT scans every 8 weeks until progression, assessed up to 25 monthsPopulation: ITT Population.
PFS (based on mRECIST) as determined by Independent Central Review is summarized for the ITT Population.
Outcome measures
| Measure |
Single Agent_ Cohort 1
n=3 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10\^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=24 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=5 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=20 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Progression Free Survival
|
1.7 Months
Interval 1.7 to 1.8
|
1.9 Months
Interval 1.5 to 2.0
|
2.2 Months
Interval 1.9 to 4.1
|
3.4 Months
Interval 1.8 to 5.0
|
SECONDARY outcome
Timeframe: Monthly until Death or Lost-to-Followup, assessed up to 25 monthsPopulation: ITT Population.
Compare overall survival time of patients treated with JX-594 alone or in combination with irinotecan
Outcome measures
| Measure |
Single Agent_ Cohort 1
n=3 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10\^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=24 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=5 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=20 Participants
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: RAC VAC GM-CSF JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Overall Survival
|
4.9 Months
Interval 3.1 to 15.1
|
3.4 Months
Interval 2.6 to 6.4
|
4.1 Months
Interval 2.2 to 10.3
|
6.4 Months
Interval 3.6 to 9.3
|
Adverse Events
Single Agent_ Cohort 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Single Agent_Cohort 2
Serious events: 10 serious events
Other events: 25 other events
Deaths: 24 deaths
Combination_Cohort 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 5 deaths
Combination_Cohort 4
Serious events: 8 serious events
Other events: 17 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Single Agent_ Cohort 1
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Irinotecan: 180 mg/m2 IV every 2 weeks.
Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Disease progression
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Troponin increased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
Other adverse events
| Measure |
Single Agent_ Cohort 1
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29
|
Single Agent_Cohort 2
n=25 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29
|
Combination_Cohort 3
n=4 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Irinotecan: 180 mg/m2 IV every 2 weeks.
Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
Combination_Cohort 4
n=17 participants at risk
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
24.0%
6/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
35.3%
6/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Cardiac disorders
Tachycardia
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
24.0%
6/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
41.2%
7/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Cardiac disorders
Ventricular hypokinesia
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Eye disorders
Eyepain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
16.0%
4/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
28.0%
7/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
29.4%
5/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
29.4%
5/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
47.1%
8/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
52.0%
13/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
82.4%
14/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
48.0%
12/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
58.8%
10/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Asthenia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Chills
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
76.0%
19/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
88.2%
15/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Device occlusion
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Disease progression
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Fatigue
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
28.0%
7/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
70.6%
12/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Hypothermia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Injection site pain
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Localised oedema
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Malaise
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Mass
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Medical device complication
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
28.0%
7/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
23.5%
4/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Pain
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
General disorders
Pyrexia
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
92.0%
23/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
17/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Folliculitis
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Gingivitis
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Lip infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Rash pustular
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
44.0%
11/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
35.3%
6/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Splinter
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
16.0%
4/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
32.0%
8/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Troponin increased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
Weight increased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
16.0%
4/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
100.0%
4/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
41.2%
7/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
23.5%
4/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
23.5%
4/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
29.4%
5/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
20.0%
5/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Extensor plantar response
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
48.0%
12/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
41.2%
7/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
17.6%
3/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Psychiatric disorders
Encopresis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Urinary retention
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
24.0%
6/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
35.3%
6/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Capillaritis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
12.0%
3/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rash maculo-papular
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
8.0%
2/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
11.8%
2/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
5.9%
1/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
4.0%
1/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
20.0%
5/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
41.2%
7/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
64.0%
16/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
75.0%
3/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
64.7%
11/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
|
Vascular disorders
Phlebitis
|
25.0%
1/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/25 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/4 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
0.00%
0/17 • 2 years
Efficacy endpoints including Overall Survival, as well as All-Cause Mortality, were analyzed based on the Intent-to-Treat (ITT) population (N=52). However, other safety data including Serious and Other (Not Serious) Adverse Events were assessed based on the Safety population (N=50), which includes only patients who received at least one dose of the study drug.
|
Additional Information
Seunghyun Ma, M.D., Ph.D., Chief Medical Officer
SillaJen Biotherapeutics, Inc.
Phone: (415) 281-8886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place