Trial Outcomes & Findings for Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma (NCT NCT03929029)
NCT ID: NCT03929029
Last Updated: 2026-01-05
Results Overview
DLT (Protocol Section 5.5) definition: 1. Grade 3 or 4 toxicity that is definitely, probably, or possibly related to administration of vaccine, excluding transient (≤ 72 hours) flu-like symptoms; grade 3 nausea, vomiting, diarrhea, or constipation that returns to grade 2 (or lower) within 48 hours; any grade 3 rash that resolves to grade 2 or lower within 14 days; any grade 3 endocrine abnormality that is corrected with hormonal therapy within 4 weeks. 2. Grade 3 or 4 abnormal laboratory value that is at least possibly related to the administration of vaccine lasting for more than 7 days and requires hospitalization or medical intervention. Excludes any grade 3 electrolyte abnormality that: lasts ≤ 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical intervention. 3. Any grade 3 or grade 4 toxicity that is considered, in the opinion of the Principal Investigator, to be dose-limiting. 4. Any death related to study treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
7 weeks after first dose of NeoVax
Results posted on
2026-01-05
Participant Flow
Participants were recruited from the Dana-Farber/Harvard Cancer Center and were required to have histologically confirmed stage IIIB/C/D or stage IV cutaneous melanoma (mucosal or uveal melanomas were excluded). At least one site of disease must have been resectable, partially-resectable, or amenable to core biopsies to provide tumor tissue for sequence analysis. Participants were enrolled between November 2020 and July 2022.
Participant milestones
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
* NIvolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
|---|---|---|
|
Nivolumab Lead-In (Weeks 1-12)
STARTED
|
6
|
5
|
|
Nivolumab Lead-In (Weeks 1-12)
COMPLETED
|
6
|
5
|
|
Nivolumab Lead-In (Weeks 1-12)
NOT COMPLETED
|
0
|
0
|
|
Nivo, NeoVax, Ipilimumab (Weeks 12-21)
STARTED
|
5
|
5
|
|
Nivo, NeoVax, Ipilimumab (Weeks 12-21)
COMPLETED
|
5
|
5
|
|
Nivo, NeoVax, Ipilimumab (Weeks 12-21)
NOT COMPLETED
|
0
|
0
|
|
Nivolumab (Week 24+, Every 4 Weeks)
STARTED
|
4
|
4
|
|
Nivolumab (Week 24+, Every 4 Weeks)
COMPLETED
|
4
|
4
|
|
Nivolumab (Week 24+, Every 4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
n=6 Participants
* Run in period will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
n=5 Participants
* Run in period will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 Years
n=9667 Participants
|
57 Years
n=6597 Participants
|
57 Years
n=16264 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
8 Participants
n=16264 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9667 Participants
|
5 Participants
n=6597 Participants
|
10 Participants
n=16264 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
9 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
2 Participants
n=16264 Participants
|
|
Melanoma AJCC Stage
Stage III
|
4 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
8 Participants
n=16264 Participants
|
|
Melanoma AJCC Stage
Stage IV
|
2 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
PRIMARY outcome
Timeframe: 7 weeks after first dose of NeoVaxPopulation: Patients who received at least 2 NeoVax administrations.
DLT (Protocol Section 5.5) definition: 1. Grade 3 or 4 toxicity that is definitely, probably, or possibly related to administration of vaccine, excluding transient (≤ 72 hours) flu-like symptoms; grade 3 nausea, vomiting, diarrhea, or constipation that returns to grade 2 (or lower) within 48 hours; any grade 3 rash that resolves to grade 2 or lower within 14 days; any grade 3 endocrine abnormality that is corrected with hormonal therapy within 4 weeks. 2. Grade 3 or 4 abnormal laboratory value that is at least possibly related to the administration of vaccine lasting for more than 7 days and requires hospitalization or medical intervention. Excludes any grade 3 electrolyte abnormality that: lasts ≤ 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical intervention. 3. Any grade 3 or grade 4 toxicity that is considered, in the opinion of the Principal Investigator, to be dose-limiting. 4. Any death related to study treatment.
Outcome measures
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
n=5 Participants
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
n=5 Participants
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
|---|---|---|
|
Number of Participants With Dose-Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after first administration of NeoVaxPopulation: Patients who received at least two doses of NeoVax.
The number of patients who had a best response to therapy of complete or partial response, as assessed by RECIST (Response Evaluation Criteria in Solid Tumors, Version 1.1). Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease of the sum of the diameters of target lesions; Progressive disease (PD): At least 20% increase in the sum of the diameters of target lesions; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
n=5 Participants
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
n=5 Participants
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
|---|---|---|
|
Number of Patients With Objective Response
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients who received at least 2 NeoVax administrations.
Number of patients with unresectable disease who experience disease progression (PD), per RECIST 1.1, or who had resectable disease and who experience disease recurrence.
Outcome measures
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
n=5 Participants
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
n=5 Participants
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
|---|---|---|
|
Number of Patients With Disease Progression/Recurrence
|
2 Participants
|
1 Participants
|
Adverse Events
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
n=6 participants at risk
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
n=5 participants at risk
* NIvolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Skin Infection
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
Other adverse events
| Measure |
Nivolumab, NeoVax + Montanide, Ipilimumab (2.5 mg Per Injection Site)
n=6 participants at risk
* Nivolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (2.5 mg per injection site).
|
Nivolumab, NeoVax + Montanide, Ipilimumab (5.0 mg Per Injection Site)
n=5 participants at risk
* NIvolumab will begin within 2 weeks of metastatic tissue biopsy
* Patients will receive Nivolumab at a flat dose I.V. infusion every 4 weeks (28 days) during vaccine preparation
* Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21
* Concurrent with NeoVax plus Montanide administration, patients will receive Ipilimumab injection on weeks 12, 15, 18, and 21 (5.0 mg per injection site).
|
|---|---|---|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
40.0%
2/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Eye disorders
Cataract
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Eye disorders
Subconjunctival Hemorrhage
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
40.0%
2/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 14 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
3/6 • Number of events 5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 13 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Edema trunk
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 13 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
100.0%
5/5 • Number of events 10 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Flu like symptoms
|
16.7%
1/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
80.0%
4/5 • Number of events 10 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Injection site reaction
|
66.7%
4/6 • Number of events 14 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
80.0%
4/5 • Number of events 7 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Localized edema
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Malaise
|
33.3%
2/6 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
General disorders
Pain
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
COVID-19 Infection
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
40.0%
2/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Gum infection
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Herpes simplex reactivation
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Prostate infection
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Skin infection
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 8 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
40.0%
2/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
40.0%
2/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
83.3%
5/6 • Number of events 8 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
80.0%
4/5 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • Number of events 6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Creatinine increased
|
33.3%
2/6 • Number of events 5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 13 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Number of events 7 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Serum amylase increased
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Thyroid stimulating hormone increased
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Weight gain
|
33.3%
2/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
Weight loss
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Number of events 13 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
4/6 • Number of events 15 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Syndrome
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Left Thumb Ucl Tear
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tension Dysphonia
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
PMR
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
40.0%
2/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bilateral Saccular Cysts
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma In Situ
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
16.7%
1/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 4 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
80.0%
4/5 • Number of events 5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Nervous system disorders
Paresthesia
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczematous Dermatitis
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Grover's Disease
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Lentigines
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 3 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
60.0%
3/5 • Number of events 7 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Seborrheic Keratosis
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Tenderness And Redness At Biopsy Site
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Skin and subcutaneous tissue disorders
Xerosis Cutis
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Axillary Lymphadenectomy
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Drain For Lymphdenectomy
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Excision Of Left Lower Leg Melanoma
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Kidney Biopsy
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Left Thumb Ulnar Collateral Ligament Repair
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Surgical and medical procedures
Resection Of Peritoneal Mass
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 2 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
0.00%
0/5 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
|
Vascular disorders
Lymphedema
|
16.7%
1/6 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
20.0%
1/5 • Number of events 1 • All patients who received any protocol therapy were followed for up to 2 years for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place