Trial Outcomes & Findings for Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing (NCT NCT01730118)
NCT ID: NCT01730118
Last Updated: 2022-09-10
Results Overview
Cardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is \>-53%. Below 53% is a cardiac dysfunction.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Baseline through receipt of last dose of vaccine, up to 24 weeks
Results posted on
2022-09-10
Participant Flow
Participant milestones
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation
STARTED
|
6
|
7
|
6
|
6
|
0
|
0
|
2
|
|
Dose Escalation
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Dose Escalation
NOT COMPLETED
|
6
|
7
|
3
|
6
|
0
|
0
|
2
|
|
Dose Expansion
STARTED
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
|
Dose Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Dose Escalation
Death on study
|
5
|
7
|
2
|
6
|
0
|
0
|
0
|
|
Dose Escalation
Died before treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Escalation
Chose to start a different treatment
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dose Escalation
Disease progression prior to treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Expansion
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion
Other medical condition
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Expansion
Disease progression
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dose Expansion
Inability to return
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dose Expansion
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing
Baseline characteristics by cohort
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
n=7 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
n=2 Participants
Participants were enrolled on the study but not treated.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
|
Age, Continuous
|
48.28 years
STANDARD_DEVIATION 10.21 • n=99 Participants
|
57.1 years
STANDARD_DEVIATION 7.92 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
62.65 years
STANDARD_DEVIATION 5.08 • n=7 Participants
|
60.03 years
STANDARD_DEVIATION 2.11 • n=31 Participants
|
56.33 years
STANDARD_DEVIATION 7.62 • n=30 Participants
|
63.9 years
STANDARD_DEVIATION 11.74 • n=3 Participants
|
58.46 years
STANDARD_DEVIATION 8.89 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
32 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
3 participants
n=31 Participants
|
3 participants
n=30 Participants
|
2 participants
n=3 Participants
|
33 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline through receipt of last dose of vaccine, up to 24 weeksCardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is \>-53%. Below 53% is a cardiac dysfunction.
Outcome measures
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
n=7 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Cardiac Toxicity
Cardiac Dysfunction - LVEF below 53%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Cardiac Toxicity
Normal LVEF >-53%
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline through last dose of vaccine, up to 24 weeksPopulation: Not all participants had samples for analyses. Samples from 13 participants were analyzed in the following groups.
Vaccine immunogenicity was determined by the number of participants who develop at least a 4-fold increase in antibody dilution titers over baseline at the time points measured. The antibody response following the vaccination was assessed using peptide-array and reported as fold increase compared to the baseline values using the cut-off of 4 fold per study definition of the vaccine immunogenicity and also of 2.5 fold to aid the interpretation of the result.
Outcome measures
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=1 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
n=4 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=4 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=4 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers
4-fold Increase
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers
2.5- fold Increase
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 8, 16, 24, 36, 48, 76, 100, and 124 weeks after initial vaccinationPopulation: Not all participants were available for analyses. Twenty one participants were evaluable.
Number of participants who experienced tumor shrinkage or stabilization that is sufficient by modified immune response related criteria (irRC) to be considered stable disease (SD), a partial response (PR) or better (complete response (CR). SD is neither partial response nor progressive disease (PD). PR is ≥ 30% decrease in tumor burden compared with baseline, confirmation required. CR is disappearance of all target and non-target lesions. Lymph nodes must regress to \<10mm short axis. No new lesions, confirmation required. PD ≥ 20% increase in tumor burden compared with baseline, with nadir, or reset baseline. New lesions added to the tumor burden, confirmation required.
Outcome measures
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=5 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
n=7 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=4 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=1 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=1 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 8
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 8
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 16
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 16
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 24
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 24
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 36
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 36
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 36
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 48
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 48
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 48
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 76
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 76
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 76
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 100
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 100
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 100
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Stable Disease at Week 124
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Partial Response at Week 124
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
Complete Response at Week 124
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)
n=7 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 Participants
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
n=2 Participants
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
Part I Dose Escalation Level 2 -10x10^6 Total Nucleated Cells (TNCs)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 7 deaths
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Enrolled But Not Treated
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=6 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 -10x10^6 Total Nucleated Cells (TNCs)
n=7 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
n=2 participants at risk
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Death NOS
|
83.3%
5/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
100.0%
7/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 16 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Bladder spasm
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Bronchial infection
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, Biliary obstruction
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 48 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 18 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Infections and infestations - Other, left renal abscess
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Serum amylase increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
Other adverse events
| Measure |
Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)
n=6 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
5x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 2 -10x10^6 Total Nucleated Cells (TNCs)
n=7 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
10x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)
n=6 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
20x10\^6 Total Nucleated Cells (TNCs)
|
Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)
n=3 participants at risk
Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.
40x10\^6 Total Nucleated Cells (TNCs)
|
Enrolled But Not Treated
n=2 participants at risk
Participants were enrolled on the study but not treated.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Epigastric abdominal discomfort
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Left sided abdominal discomfort
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, food poisoning
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
42.9%
3/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
4/6 • Number of events 47 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 14 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
42.9%
3/7 • Number of events 30 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 30 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 27 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 30 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 36 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
57.1%
4/7 • Number of events 21 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
50.0%
3/6 • Number of events 32 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
2/3 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
2/3 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 11 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 35 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
3/6 • Number of events 11 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 24 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 20 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Bladder spasm
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Bloating
|
33.3%
2/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Swollen lymph nodes. Left supraclavical area.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 25 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 21 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
CPK increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 45 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Cardiac disorders
Cardiac disorders - Other, Mid RV dilation
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • Number of events 9 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 30 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Chills
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 20 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
42.9%
3/7 • Number of events 14 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 44 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
2/3 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 18 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
4/6 • Number of events 54 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Eye disorders
Eye disorders - Other, Look like fleas/consult ophthalmology
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Eye disorders
Eye disorders - Other, Transient light flashes in eyes
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Eye disorders
Eye disorders - Other, Specify
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
57.1%
4/7 • Number of events 47 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
50.0%
3/6 • Number of events 23 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
100.0%
6/6 • Number of events 61 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Fever
|
33.3%
2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 24 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Abdominal discomfort
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 41 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
3/6 • Number of events 20 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
50.0%
3/6 • Number of events 62 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
4/6 • Number of events 57 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Infections and infestations - Other, Cyst R-scapular
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Infections and infestations - Other, Pneumocystis carina pneumonia or PJP
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Injection site reaction
|
83.3%
5/6 • Number of events 85 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
100.0%
7/7 • Number of events 277 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
83.3%
5/6 • Number of events 513 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
100.0%
6/6 • Number of events 396 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
2/3 • Number of events 70 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
100.0%
3/3 • Number of events 138 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 24 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Kidney infection
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 20 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Number of events 20 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 34 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
4/6 • Number of events 189 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
4/6 • Number of events 42 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
66.7%
2/3 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Malaise
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Muscle spasm
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 24 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 26 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
42.9%
3/7 • Number of events 18 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 36 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
General disorders
Pain
|
50.0%
3/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 41 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
50.0%
3/6 • Number of events 88 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 14 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Ciprofloxacine 250mg twice a day for 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Pyruria on Levaquin
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Serum amylase increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Left inguinal itch and redness.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, right nephrostomy placement, ureteroscopy
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
50.0%
3/6 • Number of events 42 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 30 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
28.6%
2/7 • Number of events 19 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 38 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 15 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
71.4%
5/7 • Number of events 24 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 13 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Weight gain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
57.1%
4/7 • Number of events 21 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
16.7%
1/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
2/6 • Number of events 30 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
33.3%
1/3 • Number of events 10 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place