Trial Outcomes & Findings for Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists (NCT NCT02126579)
NCT ID: NCT02126579
Last Updated: 2024-02-28
Results Overview
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2024-02-28
Participant Flow
After enrolling 49 participants across all 7 arms in accord with the study objectives, the study was amended to allow enrollment of an additional cohort on arm E (part 2) as a neoadjuvant vaccine with biopsies pre- and post-vaccine. However, only 1 patient enrolled on part 2 arm E; thus, we closed the study. Analysis of 1 patient would not satisfy the goals of that neoadjuvant component; so, we include data for the part 2 Arm E participant in Arm E for reporting purposes.
Participant milestones
| Measure |
Arm A (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + Part 2)
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm F (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
4
|
6
|
16
|
6
|
6
|
|
Overall Study
Received at Least 3 Vaccines
|
5
|
7
|
4
|
6
|
16
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
7
|
4
|
5
|
16
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + Part 2)
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm F (Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
|---|---|---|---|---|---|---|---|
|
Overall Study
disease progression
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
Baseline characteristics by cohort
| Measure |
Arm A (Part 1)
n=5 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
n=7 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
n=4 Participants
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + 2)
n=16 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously.
Except that the last patient, on Part 2 received all 6 vaccines in the same site and did not receive tetanus peptide.
|
Arm F (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Median Age
|
52 years
n=99 Participants
|
64 years
n=107 Participants
|
64 years
n=206 Participants
|
53 years
n=7 Participants
|
60 years
n=31 Participants
|
56 years
n=30 Participants
|
59 years
n=3 Participants
|
58 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
50 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
49 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
4 participants
n=206 Participants
|
6 participants
n=7 Participants
|
16 participants
n=31 Participants
|
6 participants
n=30 Participants
|
6 participants
n=3 Participants
|
50 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants enrolled and treated.
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.
Outcome measures
| Measure |
Arm A (Part 1)
n=5 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
n=7 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
n=4 Participants
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + Part 2)
n=16 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm F (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GASTROINTESTINAL - Constipation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GASTROINTESTINAL - Diarrhea
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
BLOOD/LYMPHATIC - Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Injection site reaction
|
5 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
15 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Localized edema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
IMMUNE SYSTEM - Autoimmune disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
INJURY/POISONING/PROCEDURAL - Bruising
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Pruritus
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
VASCULAR - Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GASTROINTESTINAL - Mucositis oral
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GASTROINTESTINAL - Nausea
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GASTROINTESTINAL - Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
EAR/LABYRINTH - Tinnitus
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GASTROINTESTINAL - Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Chills
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
12 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Fatigue
|
4 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
12 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Flu like symptoms
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Other
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
GENERAL AND ADMINISTRATION SITE - Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
INVESTIGATIONS - Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
INVESTIGATIONS - Weight loss
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
INVESTIGATIONS - White blood cell decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
METABOLISM/NUTRITION - Anorexia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
MUSCULOSKELETAL/CONNECTIVE TISSUE - Other
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
NERVOUS SYSTEM - Dizziness
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
NERVOUS SYSTEM - Dysgeusia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
NERVOUS SYSTEM - Headache
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
PSYCHIATRIC - Anxiety
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
RESPIRATORY/THORACIC/MEDIASTINAL - Cough
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Pain of skin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Scalp pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Skin induration
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
14 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
SKIN/SUBCUTANEOUS TISSUE - Skin ulceration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
VASCULAR - Flushing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-related Adverse Events Per Study Arm
VASCULAR - Hot flashes
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 monthsLevels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
Outcome measures
| Measure |
Arm A (Part 1)
n=5 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
n=7 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
n=4 Participants
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + Part 2)
n=16 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm F (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
|---|---|---|---|---|---|---|---|
|
T Cell Response in Peripheral Blood Over Duration of Study Participation
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsCD4+ T cell responses to peptides in the vaccine, and their function
Outcome measures
| Measure |
Arm A (Part 1)
n=5 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
n=7 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
n=4 Participants
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + Part 2)
n=16 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm F (Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
n=6 Participants
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
|---|---|---|---|---|---|---|---|
|
T Cell Response and Function in Peripheral Blood
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Arm A (Part 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B (Part 1)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Arm C (Part 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm D (Part 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Arm E (Part 1 + 2)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 1 deaths
Arm F (Part 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm G(Part 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A (Part 1)
n=5 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm B (Part 1)
n=7 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
|
Arm C (Part 1)
n=4 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after the vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm D (Part 1)
n=6 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
|
Arm E (Part 1 + 2)
n=16 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
IFA: 2 mL administered half intradermally and half subcutaneously
Except that one participant on Part 2 did not have tetanus peptide in the vaccine, and that participants vaccines were all administered at the same vaccine site.
|
Arm F (Part 1)
n=6 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
Arm G(Part 1)
n=6 participants at risk
Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.
Resiquimod will be applied to the vaccine site immediately after vaccine administration.
Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.
PolyICLC: 1 mL administered half intradermally and half subcutaneously
Resiquimod: 500 mg applied to vaccine site after vaccine administration
IFA: 2 mL administered half intradermally and half subcutaneously
|
|---|---|---|---|---|---|---|---|
|
General disorders
Chills
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
42.9%
3/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
75.0%
12/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
66.7%
4/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Blood and lymphatic system disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Ear and labyrinth disorders
Tinnitus
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
2/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
37.5%
6/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Fatigue
|
80.0%
4/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
71.4%
5/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
75.0%
12/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
66.7%
4/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Fever
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
8/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Flu-like symptoms
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Injection site reaction
|
100.0%
5/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
85.7%
6/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
2/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
100.0%
6/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
93.8%
15/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
100.0%
6/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
100.0%
6/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Localized edema
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Pain
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
18.8%
3/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Other
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
28.6%
2/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
43.8%
7/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Investigations
lymphocyte count decreased
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Investigations
weight loss
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Investigations
white blood cell decreased
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
28.6%
2/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
43.8%
7/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
66.7%
4/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
60.0%
3/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
28.6%
2/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
43.8%
7/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
42.9%
3/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
37.5%
6/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Allergic rhinitis
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
42.9%
3/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
18.8%
3/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
57.1%
4/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
57.1%
4/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
43.8%
7/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
40.0%
2/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Rash - maculopapular
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
28.6%
2/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
scalp pain
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
80.0%
4/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
28.6%
2/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
2/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
87.5%
14/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
83.3%
5/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
31.2%
5/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Vascular disorders
Hot flashes
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
50.0%
3/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
12.5%
2/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Vascular disorders
Hematoma
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Cardiac disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Eye disorders
Blurred vision
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Eye disorders
Flashing lights
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Eye disorders
Floaters
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Eye disorders
Night blindness
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Eye disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Eye disorders
Watering eyes
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Edema limbs
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
28.6%
2/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
General disorders
Edema trunk
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Infections and infestations
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Injury, poisoning and procedural complications
Venous Injury
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Investigations
Weight gain
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
25.0%
1/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Nervous system disorders
Presyncope
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Psychiatric disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
14.3%
1/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Renal and urinary disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
33.3%
2/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
16.7%
1/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
|
Skin and subcutaneous tissue disorders
Other
|
0.00%
0/5 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/7 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/4 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
6.2%
1/16 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
0.00%
0/6 • 6 months
All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study
|
Additional Information
Craig Slingluff, MD; Professor, Department of Surgery; Program Director, UVA Cancer Center
University of Virginia
Phone: 4349249311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place