Trial Outcomes & Findings for Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells. (NCT NCT00289341)
NCT ID: NCT00289341
Last Updated: 2013-01-18
Results Overview
Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
End of blinded phase (wk 9)
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
Dendritic Cells Pulsed With LNCaP (DC/LNCaP)
12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
|
Placebo
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.
Baseline characteristics by cohort
| Measure |
Dendritic Cells Pulsed With LNCaP (DC/LNCaP)
n=12 Participants
12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
|
Placebo
n=12 Participants
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
62.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of blinded phase (wk 9)Population: All AEs occurring 5 or more times during the study were analyzed. All AEs reported are grade 1 except as noted.
Occurrence of adverse events (AE) was compared between the placebo and vaccine groups during the blinded phase (the 1st 9 weeks). At the end of this phase, all were unblinded, and those who received placebo crossed over to now receive vaccine. All serious AEs and any other AEs that occurred 5 times or more are reported. The exact binomial test was used to compare the occurrence of each AE between groups.
Outcome measures
| Measure |
Dendritic Cells Pulsed With LNCaP (DC/LNCaP)
n=12 Participants
12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
|
Placebo
n=12 Participants
12 patients receiving vehicle only
|
|---|---|---|
|
Adverse Event
injection site reaction
|
22 Adverse Events
|
2 Adverse Events
|
|
Adverse Event
injection site reaction (grade 2)
|
4 Adverse Events
|
0 Adverse Events
|
|
Adverse Event
albumin, serum, low
|
0 Adverse Events
|
1 Adverse Events
|
|
Adverse Event
albumin, urine, high
|
2 Adverse Events
|
3 Adverse Events
|
|
Adverse Event
ALT, serum, high
|
3 Adverse Events
|
4 Adverse Events
|
|
Adverse Event
ANA, high
|
1 Adverse Events
|
1 Adverse Events
|
|
Adverse Event
BUN, serum, high
|
4 Adverse Events
|
1 Adverse Events
|
|
Adverse Event
chloride, serum, high
|
1 Adverse Events
|
4 Adverse Events
|
|
Adverse Event
CO2 serum, low
|
3 Adverse Events
|
4 Adverse Events
|
|
Adverse Event
creatinine, serum, high
|
3 Adverse Events
|
1 Adverse Events
|
|
Adverse Event
diarrhea/loose stools
|
5 Adverse Events
|
1 Adverse Events
|
|
Adverse Event
edema, lower extremities
|
0 Adverse Events
|
2 Adverse Events
|
|
Adverse Event
eosinophils, high
|
1 Adverse Events
|
3 Adverse Events
|
|
Adverse Event
fatigue
|
6 Adverse Events
|
5 Adverse Events
|
|
Adverse Event
glucose, serum, high, non-fasting
|
6 Adverse Events
|
5 Adverse Events
|
|
Adverse Event
ketones, urine, high
|
1 Adverse Events
|
2 Adverse Events
|
|
Adverse Event
potassium, serum, high
|
0 Adverse Events
|
3 Adverse Events
|
|
Adverse Event
potassium, serum, high (grade 2)
|
0 Adverse Events
|
1 Adverse Events
|
|
Adverse Event
rash
|
2 Adverse Events
|
2 Adverse Events
|
|
Adverse Event
URI
|
3 Adverse Events
|
3 Adverse Events
|
|
Adverse Event
Hospitalization: cardioversion/atrial fibrillation
|
1 Adverse Events
|
0 Adverse Events
|
PRIMARY outcome
Timeframe: pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13Population: The Arm/Group Title is different for this outcome. In the 1st outcome analysis, AEs were being compared between placebo and tx groups. After the blinded phase, placebo pts crossover and we compare pre-vs post vaccination T cell proliferation in all pts. 22 of 24 pts'assays were analyzed. Two were excluded as they failed internal controls.
The difference between post minus pre-vaccination bulk T cell proliferation was calculated for each antigen.
Outcome measures
| Measure |
Dendritic Cells Pulsed With LNCaP (DC/LNCaP)
n=22 Participants
12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
|
Placebo
12 patients receiving vehicle only
|
|---|---|---|
|
Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.
No Antigen
|
4375.64 cells *10^3 per minute
Interval -1105.5989 to 10661.4237
|
—
|
|
Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.
KLH
|
16873.92 cells *10^3 per minute
Interval 5105.6543 to 28642.1867
|
—
|
|
Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.
LNCaP
|
20334.1581 cells *10^3 per minute
Interval 4265.9125 to 36402.4037
|
—
|
|
Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.
PC3
|
23950.125 cells *10^3 per minute
Interval 7006.2329 to 40894.0171
|
—
|
|
Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.
Control Antigen (3T3)
|
10299.3967 cells *10^3 per minute
Interval -777.3295 to 21376.1229
|
—
|
SECONDARY outcome
Timeframe: pre- vs post- vaccination PSA slopes.Population: 23 of 24 patients were analyzed. 1 patient was not evaluable.
To model the evolution of PSA (in log-scale) during the three study phases (pre-vaccine, vaccine, and post-vaccine phases), a mixed linear spline model was used. Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase. To account for the heterogeneous treatment effect and the repeated measures structure, random effects are incorporated into the model. For the general model, random effects for the intercept, slope and the first knot were considered.
Outcome measures
| Measure |
Dendritic Cells Pulsed With LNCaP (DC/LNCaP)
n=23 Participants
12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
|
Placebo
12 patients receiving vehicle only
|
|---|---|---|
|
Change in PSA Slope, Pre- vs Post-vaccination.
|
-0.093 log₂(ng/ml)/month
Interval -0.1694 to -0.0166
|
—
|
Adverse Events
Arm 2 Placebo Phase
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 1 Vaccine Phase
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2 Vaccine Phase
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 1 and 2 Post-Vaccination Phase
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 2 Placebo Phase
n=12 participants at risk
Single-blind
|
Arm 1 Vaccine Phase
n=12 participants at risk
Single blind
|
Arm 2 Vaccine Phase
n=12 participants at risk
Unblinded
|
Arm 1 and 2 Post-Vaccination Phase
n=24 participants at risk
unblinded
|
|---|---|---|---|---|
|
Surgical and medical procedures
Elective Hospitalization: inguinal hernia repair
|
—
0/0 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • Number of events 1 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Gastrointestinal disorders
Elective Hosptalization: cholecystectomy
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • Number of events 1 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Cardiac disorders
Hospitalization: cardioversion for atrial fibrillation
|
—
0/0 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • Number of events 1 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Renal and urinary disorders
Hospitalization: urinary retention
|
—
0/0 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • Number of events 1 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
Other adverse events
| Measure |
Arm 2 Placebo Phase
n=12 participants at risk
Single-blind
|
Arm 1 Vaccine Phase
n=12 participants at risk
Single blind
|
Arm 2 Vaccine Phase
n=12 participants at risk
Unblinded
|
Arm 1 and 2 Post-Vaccination Phase
n=24 participants at risk
unblinded
|
|---|---|---|---|---|
|
General disorders
ALT, serum, high
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
2/24 • Number of events 2 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
ANA
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
4/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
BUN, serum, high
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
CO2, serum, low
|
33.3%
4/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
albumin, serum, low
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
albumin, urine, high
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
12.5%
3/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
chloride, serum, high
|
33.3%
4/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
2/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
creatinine, serum, high
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
2/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Gastrointestinal disorders
diarrhea/loose stools
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
edema, lower extremities
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Blood and lymphatic system disorders
eosinophils, high
|
25.0%
3/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
fatigue
|
41.7%
5/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
41.7%
5/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
33.3%
4/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
glucose, serum, high, non-fasting
|
41.7%
5/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
50.0%
6/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
25.0%
6/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Renal and urinary disorders
ketones, urine, high
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
12.5%
3/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
General disorders
potassium, serum, high
|
33.3%
4/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
41.7%
5/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
4.2%
1/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
|
Skin and subcutaneous tissue disorders
rash
|
16.7%
2/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
1/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
0.00%
0/12 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
8.3%
2/24 • AEs were collected for 29 weeks.
All AEs other than SAEs are Grade 1 (NCI, CTCAE). As this reporting table does not allow having 2 arms initially then 1, all AEs are entered as 1 arm. Specifics for each arm separately is reported in Outcome 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place