Trial Outcomes & Findings for Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer (NCT NCT03190265)
NCT ID: NCT03190265
Last Updated: 2024-08-07
Results Overview
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
18 months
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Arm B: Nivolumab, Ipilimumab, CRS-207
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
n=31 Participants
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Arm B: Nivolumab, Ipilimumab, CRS-207
n=30 Participants
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Only 29/30 participants in Arm A were evaluable for this endpoint. One participant was not evaluable after they discontinued prior to their first scan for a reason other than toxicity or progression.
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
Outcome measures
| Measure |
Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207
n=29 Participants
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Arm B: Nivolumab, Ipilimumab, CRS-207
n=27 Participants
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
|
|---|---|---|
|
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 21 monthsWhen calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.
Outcome measures
| Measure |
Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207
n=30 Participants
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Arm B: Nivolumab, Ipilimumab, CRS-207
n=27 Participants
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
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|---|---|---|
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Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)
|
10 Participants
|
10 Participants
|
Adverse Events
Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207
Serious events: 24 serious events
Other events: 30 other events
Deaths: 28 deaths
Arm B: Nivolumab, Ipilimumab, CRS-207
Serious events: 21 serious events
Other events: 27 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207
n=30 participants at risk
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Arm B: Nivolumab, Ipilimumab, CRS-207
n=27 participants at risk
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Endocrine disorders
Adrenal insufficiency
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Bacteremia
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Hepatobiliary disorders
Biliary obstruction
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Biliary tract infection
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.3%
1/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Delirium
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Disease progression
|
43.3%
13/30 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
51.9%
14/27 • Number of events 14 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Embolic or Cardiovascular Event
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Fever
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Gastroesophageal sticture
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
GI tube site bleeding
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Cerebral hemorrhage
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Blood and lymphatic system disorders
Immune Thrombocytopenia Purpura
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Listeria monocytogenes bacteremia
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Lower GI Hemorrhage
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Myocarditis
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Nephritis
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Radiculitis
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Sepsis
|
13.3%
4/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
18.5%
5/27 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Stroke
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Endocrine disorders
Thyroiditis
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Urinary tract infection
|
3.3%
1/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
Other adverse events
| Measure |
Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207
n=30 participants at risk
Cyclophosphamide: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
GVAX Pancreas Vaccine: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
|
Arm B: Nivolumab, Ipilimumab, CRS-207
n=27 participants at risk
Nivolumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
Ipilimumab: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
43.3%
13/30 • Number of events 17 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
48.1%
13/27 • Number of events 17 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Agitation
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
18.5%
5/27 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
5/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
18.5%
5/27 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
10/30 • Number of events 16 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Anorexia
|
43.3%
13/30 • Number of events 14 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
37.0%
10/27 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Anxiety
|
16.7%
5/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
5/30 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
18.5%
5/27 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Ascites
|
13.3%
4/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
14.8%
4/27 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
5/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
33.3%
9/27 • Number of events 14 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Hepatobiliary disorders
Biliary stricture
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Bloating
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
14.8%
4/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Blood bilirubin increased
|
13.3%
4/30 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Eye disorders
Blurred vision
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Bruising
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Chest pain
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Chills
|
56.7%
17/30 • Number of events 41 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
96.3%
26/27 • Number of events 80 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
8/30 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
29.6%
8/27 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
4/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Diarrhea
|
23.3%
7/30 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
33.3%
9/27 • Number of events 19 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Dizziness
|
13.3%
4/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
6/30 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
6/30 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
22.2%
6/27 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Edema limbs
|
23.3%
7/30 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Fatigue
|
43.3%
13/30 • Number of events 19 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
44.4%
12/27 • Number of events 16 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Fever
|
60.0%
18/30 • Number of events 44 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
88.9%
24/27 • Number of events 120 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
14.8%
4/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Headache
|
16.7%
5/30 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
25.9%
7/27 • Number of events 22 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Hematoma
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
4/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
2/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
22.2%
6/27 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Hypertension
|
40.0%
12/30 • Number of events 39 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
59.3%
16/27 • Number of events 50 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
3/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.3%
7/30 • Number of events 15 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.3%
1/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
18.5%
5/27 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
6/30 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Hypotension
|
30.0%
9/30 • Number of events 22 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
59.3%
16/27 • Number of events 36 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
14.8%
4/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Localized edema
|
6.7%
2/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Lymphocyte count decreased
|
43.3%
13/30 • Number of events 23 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
81.5%
22/27 • Number of events 44 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Memory impairment
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Mucositis oral
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
6/30 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
25.9%
7/27 • Number of events 14 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
16/30 • Number of events 29 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
44.4%
12/27 • Number of events 22 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
2/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
General disorders
Pain
|
13.3%
4/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
22.2%
6/27 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
3/30 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
26.7%
8/30 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
11.1%
3/27 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
9/30 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
14.8%
4/27 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Sinus bradycardia
|
26.7%
8/30 • Number of events 28 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
18.5%
5/27 • Number of events 18 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Cardiac disorders
Sinus tachycardia
|
63.3%
19/30 • Number of events 43 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
70.4%
19/27 • Number of events 58 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
6.7%
2/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
14.8%
4/27 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Vascular disorders
Thromboembolic event
|
13.3%
4/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Thrush
|
16.7%
5/30 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
3.7%
1/27 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/30 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site adminstration discomfort
|
53.3%
16/30 • Number of events 28 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site erythema
|
86.7%
26/30 • Number of events 51 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site induration
|
86.7%
26/30 • Number of events 47 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site pain
|
46.7%
14/30 • Number of events 18 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Vaccine site pruritis
|
86.7%
26/30 • Number of events 44 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
0.00%
0/27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
12/30 • Number of events 15 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
33.3%
9/27 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Weight gain
|
6.7%
2/30 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
7.4%
2/27 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
|
Investigations
Weight loss
|
63.3%
19/30 • Number of events 31 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
59.3%
16/27 • Number of events 23 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 21 months. All-cause mortality was evaluated for up to 30 months. During the survival follow-up portion of the trial, patients in both Arms A and B were evaluated for all-cause mortality past the time frame for treatment and the assessment of adverse events.
Only 30 participants in Arm A and 27 participants in Arm B were assessed for Serious and Other (Not Including Serious) Adverse Events. Four participants were withdrawn prior to their first dose of study drug (1 in Arm A and 3 in Arm B) and were therefore not assessed for Serious and Other (Not Including Serious) Adverse Events.
|
Additional Information
Dung Le, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 443-287-0002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place