Trial Outcomes & Findings for CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant (NCT NCT03560752)
NCT ID: NCT03560752
Last Updated: 2025-12-10
Results Overview
Time to neutrophil engraftment was defined as days from stem cell infusion to the first of three consecutive days of absolute neutrophil count ≥0.5 x 109/L. Delayed engraftment was defined as ≥20 days to neutrophil recovery.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to 1 year from stem cell infusion.
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
Donor (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization.
|
Receipient (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant
Baseline characteristics by cohort
| Measure |
Donor (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization.
|
Receipient (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=4 Participants
|
56 years
n=50 Participants
|
53 years
n=681 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=4 Participants
|
9 Participants
n=50 Participants
|
19 Participants
n=681 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=4 Participants
|
8 Participants
n=50 Participants
|
15 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=4 Participants
|
9 Participants
n=50 Participants
|
16 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=4 Participants
|
8 Participants
n=50 Participants
|
18 Participants
n=681 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=4 Participants
|
5 Participants
n=50 Participants
|
11 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=4 Participants
|
12 Participants
n=50 Participants
|
23 Participants
n=681 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=4 Participants
|
17 participants
n=50 Participants
|
34 participants
n=681 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year from stem cell infusion.Time to neutrophil engraftment was defined as days from stem cell infusion to the first of three consecutive days of absolute neutrophil count ≥0.5 x 109/L. Delayed engraftment was defined as ≥20 days to neutrophil recovery.
Outcome measures
| Measure |
Recipients (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|
|
Delayed Engraftment
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months from stem cell infusionAcute graft versus host disease (aGvHD) happens within days or as late as 6 months after allogeneic transplants. The three main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract.
Outcome measures
| Measure |
Recipients (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|
|
Severe (Grade III-IV) Acute Graft Versus Host Disease
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year from stem cell infusion.Toxicities were assessed in recipients by Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Recipients (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|
|
Number of Recipients With Grade 3-4 Adverse Events
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after G-CSF mobilizationToxicities were assessed in recipients by Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Recipients (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|
|
Number of Donors With Grade 2-3 Adverse Events
|
3 Participants
|
PRIMARY outcome
Timeframe: From stem cell infusion up to 100 days post-HSCT (hematopoietic stem cell transplantation).NRM was defined as death without recurrent or progressive disease after allogeneic transplant. Probabilities of NRM were estimated with the use of cumulative incidence curves, with relapse viewed as a competing risk.
Outcome measures
| Measure |
Recipients (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 Participants
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|
|
100-Day Non-Relapse Mortality (NRM)
|
0 percentage of evaluable participants
|
Adverse Events
Donor (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Receipient (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Donor (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 participants at risk
Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization.
|
Receipient (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 participants at risk
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Fever
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
Other adverse events
| Measure |
Donor (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 participants at risk
Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization.
|
Receipient (Multi-peptide CMV-modified Vaccinia Ankara Vaccine)
n=17 participants at risk
Participants undergo hematopoietic cell transplantation on day 0 and receive multi-peptide CMV-modified Vaccinia Ankara vaccine injection on days 28 and 56.
|
|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Mouth ulcer
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Chills
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 4 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Fatigue
|
58.8%
10/17 • Number of events 10 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Fever
|
23.5%
4/17 • Number of events 4 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Hair loss
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Injection site reaction
|
76.5%
13/17 • Number of events 13 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Malaise
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
General disorders
Tenderness to Jaw area
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Cholesterol high
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Creatinine increased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
Platelet count decreased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Cardiac disorders
Chest pain - cardiac
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Investigations
White blood cell decreased
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 4 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.4%
5/17 • Number of events 5 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Nervous system disorders
Headache
|
52.9%
9/17 • Number of events 10 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Skin and subcutaneous tissue disorders
scalp lesions
|
0.00%
0/17 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
5.9%
1/17 • Number of events 1 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
|
Vascular disorders
Hypertension
|
17.6%
3/17 • Number of events 3 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
11.8%
2/17 • Number of events 2 • Adverse Events were monitored/assessed from day of Triplex injection to 365 days after stem cell infusion. All-Cause Mortality was monitored/assessed up to 13 months from day of Triplex injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place