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Trial Outcomes & Findings for A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib (NCT NCT01387555)

NCT ID: NCT01387555

Last Updated: 2026-07-08

Results Overview

Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

From randomization until death from any cause, assessed up to 21 months.

Results posted on

2026-07-08

Participant Flow

Patients with advanced hepatocellular carcinoma (HCC) who had failed prior sorafenib treatment were recruited at 40 study centers across 7 countries (Canada, France, Germany, Hong Kong, South Korea, Taiwan, and the United States) between October 2011 and October 2013.

A total of 187 patients were initially screened for study eligibility. Of these, 58 patients were excluded prior to randomization. The remaining 129 eligible patients were subsequently randomized and assigned to the study arms (Arm A or Arm B).

Participant milestones

Participant milestones
Measure
JX-594 + Best Supportive Care
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Overall Study
STARTED
86
43
Overall Study
COMPLETED
11
3
Overall Study
NOT COMPLETED
75
40

Reasons for withdrawal

Reasons for withdrawal
Measure
JX-594 + Best Supportive Care
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Overall Study
Withdrawal by Subject
8
27
Overall Study
Adverse Event
13
4
Overall Study
Physician Decision
22
3
Overall Study
Death
10
2
Overall Study
Protocol Violation
0
1
Overall Study
Other unspecified reasons
14
2
Overall Study
Intercurrent Illness
8
1

Baseline Characteristics

A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
JX-594 + Best Supportive Care
n=86 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=43 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Total
n=129 Participants
Total of all reporting groups
Age, Continuous
60.2 Years
STANDARD_DEVIATION 10.70 • n=9 Participants
54.5 Years
STANDARD_DEVIATION 12.10 • n=27 Participants
58.3 Years
STANDARD_DEVIATION 11.46 • n=267 Participants
Sex: Female, Male
Female
14 Participants
n=9 Participants
10 Participants
n=27 Participants
24 Participants
n=267 Participants
Sex: Female, Male
Male
72 Participants
n=9 Participants
33 Participants
n=27 Participants
105 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Asian
52 Participants
n=9 Participants
26 Participants
n=27 Participants
78 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=9 Participants
1 Participants
n=27 Participants
3 Participants
n=267 Participants
Race (NIH/OMB)
White
30 Participants
n=9 Participants
15 Participants
n=27 Participants
45 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=9 Participants
1 Participants
n=27 Participants
3 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=9 Participants
2 Participants
n=27 Participants
5 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
83 Participants
n=9 Participants
41 Participants
n=27 Participants
124 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Region of Enrollment
South Korea
39 Participants
n=9 Participants
19 Participants
n=27 Participants
58 Participants
n=267 Participants
Region of Enrollment
United States
13 Participants
n=9 Participants
10 Participants
n=27 Participants
23 Participants
n=267 Participants
Region of Enrollment
Germany
13 Participants
n=9 Participants
0 Participants
n=27 Participants
13 Participants
n=267 Participants
Region of Enrollment
France
7 Participants
n=9 Participants
7 Participants
n=27 Participants
14 Participants
n=267 Participants
Region of Enrollment
Canada
7 Participants
n=9 Participants
2 Participants
n=27 Participants
9 Participants
n=267 Participants
Region of Enrollment
Taiwan
6 Participants
n=9 Participants
5 Participants
n=27 Participants
11 Participants
n=267 Participants
Region of Enrollment
China
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants

PRIMARY outcome

Timeframe: From randomization until death from any cause, assessed up to 21 months.

Population: Intent-to-Treat (ITT) Population

Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.

Outcome measures

Outcome measures
Measure
JX-594 + Best Supportive Care
n=86 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=43 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Survival
4.2 months
Interval 3.3 to 5.4
4.4 months
Interval 3.2 to 6.0

SECONDARY outcome

Timeframe: CT scan every six weeks until progression or death, assessed up to 21 months

Population: Intent-to-Treat (ITT) Population.

Determine time-to-tumor-progression (TTP) for JX-594 + BSC compared with BSC alone based on mRECIST for HCC. Progression is defined as 2 consecutive time points with increases in the sum of the longest diameters (SLD) of viable target tumors of at least 20% for each time point.

Outcome measures

Outcome measures
Measure
JX-594 + Best Supportive Care
n=86 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=43 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Time to Tumor Progression
1.8 months
Interval 1.5 to 2.8
2.8 months
Interval 1.5 to
Unable to evaluate due to a high percentage of censoring (insufficient number of patients with events to estimate the upper confidence limit).

SECONDARY outcome

Timeframe: Baseline to Visit 8 (Week 6 ) and Visit 11 (Week 12)

Population: Intent-to-Treat (ITT) Population. The number of participants analyzed reflects only those patients who had evaluable FACT-Hep questionnaire data at baseline.

Change in Quality of Life (QoL) over time based on the physical well-being and additional concerns domains of the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) Questionnaire. The FACT-Hep measures health-related quality of life in patients with hepatobiliary cancer. The item scores from these specific subscales are summed to compute a combined score. The combined score ranges from 0 to 100. Higher scores represent a better quality of life and a better outcome.

Outcome measures

Outcome measures
Measure
JX-594 + Best Supportive Care
n=59 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=15 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Mean Percent Change From Baseline in Quality of Life (FACT-Hep Score)
Visit 8 (Week 6)
-10.2 Percent change (%)
Standard Deviation 18.25
10.4 Percent change (%)
Standard Deviation 50.88
Mean Percent Change From Baseline in Quality of Life (FACT-Hep Score)
Visit 11 (Week 12)
-5.4 Percent change (%)
Standard Deviation 20.15
-3.6 Percent change (%)
Standard Deviation 30.03

SECONDARY outcome

Timeframe: CT scan every 6 weeks until progression or death, assessed up to 21 months

Population: Intent-to-Treat (ITT) Population

The overall disease control rate is defined as the percentage of patients achieving a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) for Hepatocellular Carcinoma (HCC). Per mRECIST for HCC, CR is the disappearance of any intratumoral arterial enhancement in all target lesions; PR is a \>=30% decrease in the sum of the longest diameters (SLD) of viable target lesions; and SD is disease that does not qualify for either PR or progressive disease. Best response over all time points after Baseline was used.

Outcome measures

Outcome measures
Measure
JX-594 + Best Supportive Care
n=86 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=43 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Overall Disease Control Rate (Tumor Response)
13 Percentage (%)
Interval 7.0 to 22.0
19 Percentage (%)
Interval 8.0 to 33.0

SECONDARY outcome

Timeframe: Up to 28 days after the last dose of study drug, assessed up to 14 months.

Population: Safety Population. The number of participants analyzed reflects only those patients who had a Baseline visit and/or received study treatment.

Safety will be assessed by the number of adverse events (AEs) and serious adverse events (SAEs)

Outcome measures

Outcome measures
Measure
JX-594 + Best Supportive Care
n=84 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=25 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Patients with at least one Serious Adverse Event (SAE)
50 participants
10 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Patients with at least one Adverse Event (AE)
84 participants
21 participants

SECONDARY outcome

Timeframe: From randomization until symptomatic progression or death, assessed up to 21 months

Population: Intent-to-Treat (ITT) Population

Symptomatic progression is defined as a decrease of 4 points or more from Baseline in the FHSI-8 questionnaire (that was confirmed 3 weeks later), or a decrease in ECOG performance status to 4, or death.

Outcome measures

Outcome measures
Measure
JX-594 + Best Supportive Care
n=86 Participants
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=43 Participants
Patients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Time-to-symptomatic-progression
2.5 months
Interval 1.9 to 2.9
2.0 months
Interval 1.5 to 3.5

Adverse Events

JX-594 + Best Supportive Care

Serious events: 50 serious events
Other events: 84 other events
Deaths: 17 deaths

Best Supportive Care

Serious events: 10 serious events
Other events: 21 other events
Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure
JX-594 + Best Supportive Care
n=84 participants at risk
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=25 participants at risk
PPatients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Gastrointestinal disorders
Abdominal distension
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Abdominal pain
4.8%
4/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Abdominal pain upper
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Alanine aminotransferase increased
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Blood and lymphatic system disorders
Anaemia
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Ascites
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Aspartate aminotransferase increased
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Asthenia
4.8%
4/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Musculoskeletal and connective tissue disorders
Back pain
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Blood bilirubin increased
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Cardiac disorders
Cardio-respiratory arrest
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Chest discomfort
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Chills
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Circulatory collapse
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Psychiatric disorders
Confusional state
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Dehydration
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Diarrhoea
0.00%
0/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Enterocolitis infectious
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Epiduritis
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Fatigue
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Fluid overload
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Gastric varices haemorrhage
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Gastrointestinal haemorrhage
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
General physical health deterioration
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Haematochezia
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Nervous system disorders
Headache
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Nervous system disorders
Hepatic encephalopathy
4.8%
4/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Hepatobiliary disorders
Hepatic failure
8.3%
7/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Hepatobiliary disorders
Hepatic haemorrhage
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Hepatitis B
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Hypertension
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Hypoglycaemia
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Hypotension
7.1%
6/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Intra-abdominal haemorrhage
0.00%
0/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Nervous system disorders
Intracranial tumour haemorrhage
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Hepatobiliary disorders
Jaundice
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Malignant ascites
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
0.00%
0/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Multi-organ failure
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Nausea
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Oesophageal varices haemorrhage
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Reproductive system and breast disorders
Pelvic pain
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Peritoneal haemorrhage
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Peritonitis bacterial
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Platelet count decreased
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Pleural effusion
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Pneumonia
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Nervous system disorders
Presyncope
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Prothrombin time shortened
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Pyrexia
8.3%
7/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Renal and urinary disorders
Renal failure acute
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Respiratory failure
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Injury, poisoning and procedural complications
Road traffic accident
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Sepsis
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Staphylococcal sepsis
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Troponin increased
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Urinary tract infection
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Vomiting
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we

Other adverse events

Other adverse events
Measure
JX-594 + Best Supportive Care
n=84 participants at risk
Patients in the JX-594 + Best Supportive Care arm will receive 1 e9 pfu (plaque forming units) total dose of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) on each of six (6) treatments over 18 weeks.
Best Supportive Care
n=25 participants at risk
PPatients in the Best Supportive Care arm will have best supportive care over 18 weeks.
Gastrointestinal disorders
Abdominal distension
17.9%
15/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Abdominal pain
38.1%
32/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
32.0%
8/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Abdominal pain upper
19.0%
16/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Alanine aminotransferase increased
15.5%
13/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Blood and lymphatic system disorders
Anaemia
26.2%
22/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
16.0%
4/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Ascites
25.0%
21/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
32.0%
8/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Aspartate aminotransferase increased
23.8%
20/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
24.0%
6/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Asthenia
19.0%
16/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
16.0%
4/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Musculoskeletal and connective tissue disorders
Back pain
13.1%
11/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Blood bilirubin increased
23.8%
20/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
16.0%
4/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Blood creatinine increased
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Blood glucose increased
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Blood potassium increased
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Blood sodium decreased
9.5%
8/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Chills
52.4%
44/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Constipation
17.9%
15/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Cough
8.3%
7/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Decreased appetite
36.9%
31/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Diarrhoea
20.2%
17/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
20.0%
5/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Nervous system disorders
Dizziness
8.3%
7/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Dyspepsia
7.1%
6/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.9%
10/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Renal and urinary disorders
Dysuria
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Fatigue
26.2%
22/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Flank pain
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Gastric varices haemorrhage
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Gastrooesophageal reflux disease
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Haemorrhoid
1.2%
1/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Nervous system disorders
Headache
16.7%
14/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Hepatobiliary disorders
Hepatic failure
8.3%
7/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Hypertension
9.5%
8/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Hypoalbuminaemia
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Metabolism and nutrition disorders
Hyponatraemia
3.6%
3/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Vascular disorders
Hypotension
28.6%
24/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Influenza like illness
23.8%
20/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Injection site pain
8.3%
7/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Psychiatric disorders
Insomnia
13.1%
11/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Lymphocyte count decreased
7.1%
6/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
24.0%
6/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
0.00%
0/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
10.7%
9/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Nausea
35.7%
30/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
16.0%
4/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Investigations
Neutrophil count decreased
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Oedema peripheral
19.0%
16/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
16.0%
4/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Oesophageal varices haemorrhage
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
7.1%
6/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Pleural effusion
10.7%
9/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Skin and subcutaneous tissue disorders
Pruritus
10.7%
9/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Skin and subcutaneous tissue disorders
Pruritus generalised
7.1%
6/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
6.0%
5/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
4.0%
1/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
General disorders
Pyrexia
79.8%
67/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Infections and infestations
Rash pustular
28.6%
24/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
0.00%
0/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Renal and urinary disorders
Urinary retention
2.4%
2/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
12.0%
3/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
Gastrointestinal disorders
Vomiting
21.4%
18/84 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we
8.0%
2/25 • All-Cause Mortality monitored/assessed up to 21 months. Adverse Events monitored/assessed from informed consent signature through 28 days after the most recent study treatment or Week 18, assessed up to 14 months.
All-Cause Mortality was assessed in the entire enrolled Intent-to-Treat (ITT) population (Arm A: 86; Arm B: 43) to be consistent with Overall Survival (Outcome Measure 1). Serious and Other (Not Including Serious) Adverse Events were assessed in the Safety Population (Arm A: 84; Arm B: 25), which includes only patients who received study treatment and/or completed Baseline assessments. The 2 patients in Arm A and 18 patients in Arm B who discontinued prior to treatment or baseline assessments we

Additional Information

Seunghyun Ma, M.D., Ph.D., Chief Medical Officer

SillaJen Biotherapeutics, Inc.

Phone: (415) 281-8886

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place