Trial Outcomes & Findings for Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer (NCT NCT01341652)
NCT ID: NCT01341652
Last Updated: 2021-01-20
Results Overview
2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
2 years
Results posted on
2021-01-20
Participant Flow
Ninety-nine participants were enrolled between 2011 and 2016 at the University of Wisconsin; University of California, San Francisco; and Johns Hopkins University.
Participant milestones
| Measure |
GM-CSF Alone
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
GM-CSF Alone
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Overall Study
Incorrect Random Assignment
|
0
|
1
|
|
Overall Study
ineligible; presence metastatic disease
|
0
|
1
|
Baseline Characteristics
Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
GM-CSF Alone
n=49 Participants
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=48 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
71 years
n=7 Participants
|
71 years
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
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Prior Treatment
Prostatectomy
|
34 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Prior Treatment
Primary Radiation Therapy
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Prior Treatment
Adjuvant Radiation Therapy
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Prior Treatment
Androgen Deprivation
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Prior Treatment
Chemotherapy
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gleason Score
less than or equal to 7
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Gleason Score
greater than 7
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Baseline Prostate-Specific Antigen (PSA)
2.0 - 10.0 ng/mL
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Baseline Prostate-Specific Antigen (PSA)
greater than 10 ng/mL
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Baseline PSA Doubling Time
less than 3 months
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Baseline PSA Doubling Time
3-6 months
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Baseline PSA Doubling Time
6-12 months
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
Outcome measures
| Measure |
GM-CSF Alone
n=49 Participants
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=48 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
2-year Metastasis-Free Survival Rate
|
42.3 percent probability
|
41.8 percent probability
|
SECONDARY outcome
Timeframe: up to 9 monthsPSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9.
Outcome measures
| Measure |
GM-CSF Alone
n=49 Participants
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=48 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Doubling Time (DT)
|
8.9 months
Interval 1.6 to 77.9
|
5.4 months
Interval 1.8 to 77.9
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Number of Severity of Adverse Events (AE) by grade complements the Adverse Events Section of this record.
Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities.
Outcome measures
| Measure |
GM-CSF Alone
n=49 Participants
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=48 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Number and Severity of Observed Toxicities
Arthritis · Did not experience this AE
|
47 Participants
|
48 Participants
|
|
Number and Severity of Observed Toxicities
Generalized Muscle Weakness · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Fatigue · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Injection Site Reaction · Did not experience this AE
|
47 Participants
|
46 Participants
|
|
Number and Severity of Observed Toxicities
Nausea · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Allergic Reaction · Grade 2
|
3 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Allergic Reaction · Grade 3
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Allergic Reaction · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Allergic Reaction · Did not experience this AE
|
46 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Shingles · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Shingles · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Shingles · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Shingles · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Sinusitis · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Sinusitis · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Sinusitis · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Sinusitis · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Arthritis · Grade 2
|
2 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Arthritis · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Arthritis · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Generalized Muscle Weakness · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Generalized Muscle Weakness · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Generalized Muscle Weakness · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Myalgia · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Myalgia · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Myalgia · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Myalgia · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Headache · Grade 2
|
1 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Headache · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Headache · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Skin Swelling · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Chills · Grade 2
|
2 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Chills · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Chills · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Chills · Did not experience this AE
|
47 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Fatigue · Grade 2
|
2 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Fatigue · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Fatigue · Did not experience this AE
|
47 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Injection Site Reaction · Grade 2
|
2 Participants
|
2 Participants
|
|
Number and Severity of Observed Toxicities
Injection Site Reaction · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Injection Site Reaction · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Nausea · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Nausea · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Nausea · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Headache · Did not experience this AE
|
48 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Paresthesia · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Paresthesia · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Paresthesia · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Paresthesia · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Syncope · Grade 2
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Syncope · Grade 3
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Syncope · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Syncope · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Rash · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Rash · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Rash · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Rash · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Skin Swelling · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Skin Swelling · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Skin Swelling · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Hot Flashes · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Hot Flashes · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Hot Flashes · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Hot Flashes · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Hypertension · Grade 2
|
1 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Hypertension · Grade 3
|
0 Participants
|
2 Participants
|
|
Number and Severity of Observed Toxicities
Hypertension · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Hypertension · Did not experience this AE
|
48 Participants
|
45 Participants
|
|
Number and Severity of Observed Toxicities
Increased ALT · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Increased ALT · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Increased ALT · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Increased ALT · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Increased AST · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Increased AST · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Increased AST · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Increased AST · Did not experience this AE
|
49 Participants
|
47 Participants
|
|
Number and Severity of Observed Toxicities
Decreased ANC · Grade 2
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Decreased ANC · Grade 3
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Decreased ANC · Grade 4
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Decreased ANC · Did not experience this AE
|
49 Participants
|
46 Participants
|
|
Number and Severity of Observed Toxicities
Decreased WBC · Grade 2
|
0 Participants
|
1 Participants
|
|
Number and Severity of Observed Toxicities
Decreased WBC · Grade 3
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Decreased WBC · Grade 4
|
0 Participants
|
0 Participants
|
|
Number and Severity of Observed Toxicities
Decreased WBC · Did not experience this AE
|
49 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsTime to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria.
Outcome measures
| Measure |
GM-CSF Alone
n=49 Participants
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=48 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Median Time to Radiographic Disease Progression
|
18.3 months
Interval 12.3 to 24.2
|
18.9 months
Interval 12.0 to 24.9
|
SECONDARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
GM-CSF Alone
n=49 Participants
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=48 Participants
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
PSA Progression Free Survival
|
9.0 months
Interval 8.8 to 12.0
|
8.9 months
Interval 6.0 to 11.8
|
Adverse Events
GM-CSF Alone
Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths
pTVG-HP Vaccine With GM-CSF
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GM-CSF Alone
n=49 participants at risk
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=50 participants at risk
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Cardiac disorders
Cardiac disorders
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Chills
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Nervous system disorders - other, specify
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Vasovagal reaction
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
Other adverse events
| Measure |
GM-CSF Alone
n=49 participants at risk
rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
pTVG-HP Vaccine With GM-CSF
n=50 participants at risk
pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Cardiac disorders
Aortic valve disease
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Eye disorders
Cataract
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Eye disorders
Watering Eyes
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Eye disorders
Eye pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 5 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Anal Pain
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Diarrhea
|
8.2%
4/49 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
16.0%
8/50 • Number of events 8 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
8.0%
4/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
12.0%
6/50 • Number of events 13 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
4/49 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Chills
|
12.2%
6/49 • Number of events 7 • up to 2 years
Adverse Events data for all participants who started the study.
|
10.0%
5/50 • Number of events 12 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Edema limbs
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Facial pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Fatigue
|
34.7%
17/49 • Number of events 51 • up to 2 years
Adverse Events data for all participants who started the study.
|
40.0%
20/50 • Number of events 38 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Fever
|
8.2%
4/49 • Number of events 7 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Flu like symptoms
|
12.2%
6/49 • Number of events 14 • up to 2 years
Adverse Events data for all participants who started the study.
|
16.0%
8/50 • Number of events 30 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Gait disturbance
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Injection site reaction
|
69.4%
34/49 • Number of events 119 • up to 2 years
Adverse Events data for all participants who started the study.
|
56.0%
28/50 • Number of events 104 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Localized edema
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Malaise
|
10.2%
5/49 • Number of events 14 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
General disorders
Pain
|
18.4%
9/49 • Number of events 10 • up to 2 years
Adverse Events data for all participants who started the study.
|
20.0%
10/50 • Number of events 13 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Immune system disorders
Allergic reaction
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
8.0%
4/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Bladder infection
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Gum infection
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Rash pustular
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Sinusitis
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
skin infection
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Tooth infection
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Upper respiratory infection
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
8.0%
4/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Infections and infestations
Urinary tract infection
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Cholesterol high
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Investigations - Other, specify
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Lymphocyte count decreased
|
6.1%
3/49 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Neutrophil count decreased
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Platelet count decreased
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Serum amylase increased
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Weight gain
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Weight loss
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
White blood cell decreased
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Investigations
Anorexia
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 5 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
8/49 • Number of events 9 • up to 2 years
Adverse Events data for all participants who started the study.
|
14.0%
7/50 • Number of events 9 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.4%
11/49 • Number of events 12 • up to 2 years
Adverse Events data for all participants who started the study.
|
20.0%
10/50 • Number of events 13 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.2%
5/49 • Number of events 5 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
10.0%
5/50 • Number of events 5 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
8.0%
4/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.3%
8/49 • Number of events 11 • up to 2 years
Adverse Events data for all participants who started the study.
|
12.0%
6/50 • Number of events 10 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
8.0%
4/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Cognitive disturbance
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Dizziness
|
14.3%
7/49 • Number of events 13 • up to 2 years
Adverse Events data for all participants who started the study.
|
18.0%
9/50 • Number of events 17 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Dysarthria
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Dysphasia
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Headache
|
22.4%
11/49 • Number of events 36 • up to 2 years
Adverse Events data for all participants who started the study.
|
14.0%
7/50 • Number of events 14 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Neuralgia
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Presyncope
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Sinus pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Spasticity
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Tremor
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Nervous system disorders
Vasovagal reaction
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Psychiatric disorders
Depression
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Bladder spasm
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
10.0%
5/50 • Number of events 6 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Urinary frequency
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Urine discoloration
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
12.0%
6/50 • Number of events 8 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
6.0%
3/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
8.2%
4/49 • Number of events 4 • up to 2 years
Adverse Events data for all participants who started the study.
|
10.0%
5/50 • Number of events 6 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
4.1%
2/49 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.1%
2/49 • Number of events 6 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.0%
1/49 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
5/49 • Number of events 9 • up to 2 years
Adverse Events data for all participants who started the study.
|
10.0%
5/50 • Number of events 5 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.2%
4/49 • Number of events 6 • up to 2 years
Adverse Events data for all participants who started the study.
|
0.00%
0/50 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.2%
5/49 • Number of events 6 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Vascular disorders
Hematoma
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Vascular disorders
Hot flashes
|
6.1%
3/49 • Number of events 8 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 2 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Vascular disorders
Hypertension
|
18.4%
9/49 • Number of events 11 • up to 2 years
Adverse Events data for all participants who started the study.
|
16.0%
8/50 • Number of events 9 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
4.0%
2/50 • Number of events 3 • up to 2 years
Adverse Events data for all participants who started the study.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/49 • up to 2 years
Adverse Events data for all participants who started the study.
|
2.0%
1/50 • Number of events 1 • up to 2 years
Adverse Events data for all participants who started the study.
|
Additional Information
Douglas McNeel
University of Wisconsin Carbone Cancer Center
Phone: 608-263-4198
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place