Trial Outcomes & Findings for Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation (NCT NCT04060277)
NCT ID: NCT04060277
Last Updated: 2025-11-14
Results Overview
Cytomegalovirus (CMV) event was defined as CMV reactivation (DNAemia \>625 IU/ml by qPCR), viremia treated by antivirals, or detection of CMV by tissue histology (end-organ disease), from Day 100 post-HCT to Day 180 post-HCT. Trial participants were quantitatively monitored for viremia, by plasma qPCR test once every two weeks (+/- 5d) from Day 100 to Day 180. CMV monitoring used standard qPCR clinical laboratory methods to evaluate CMV viral load and possible vaccine failure.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
From Day 100 to Day 180 post-hematopoietic stem cell transplant (HCT)
Results posted on
2025-11-14
Participant Flow
Due to the funding and development of a new successor multi-center trial, the study accrual was terminated early.
Participant milestones
| Measure |
Arm I (Letermovir, Triplex)
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Letermovir, Placebo)
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=171 Participants
|
33 years
n=23 Participants
|
48 years
n=306 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=306 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=171 Participants
|
3 Participants
n=23 Participants
|
4 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=171 Participants
|
2 Participants
n=23 Participants
|
5 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=171 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=306 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=171 Participants
|
3 Participants
n=23 Participants
|
6 Participants
n=306 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=306 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=171 Participants
|
3 participants
n=23 Participants
|
7 participants
n=306 Participants
|
PRIMARY outcome
Timeframe: From Day 100 to Day 180 post-hematopoietic stem cell transplant (HCT)Cytomegalovirus (CMV) event was defined as CMV reactivation (DNAemia \>625 IU/ml by qPCR), viremia treated by antivirals, or detection of CMV by tissue histology (end-organ disease), from Day 100 post-HCT to Day 180 post-HCT. Trial participants were quantitatively monitored for viremia, by plasma qPCR test once every two weeks (+/- 5d) from Day 100 to Day 180. CMV monitoring used standard qPCR clinical laboratory methods to evaluate CMV viral load and possible vaccine failure.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Number of Participants With Cytomegalovirus (CMV) Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Non-relapse mortality (NRM) was defined as death without recurrent or progressive disease after transplant. NRM was estimated with the use of cumulative incidence curves, with relapse viewed as a competing risk.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Non-Relapse Mortality at Day 180 Post-Transplant
|
0 percentage of participants
Insufficient number of participants with events
|
0 percentage of participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 100Acute GVHD was assessed and graded according to the Keystone Consensus grading system (Przepiorka, D., et al., 1994 Consensus Conference on Acute GVHD Grading).
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Number of Participants With Severe (Grade 3-4) Acute Graft Versus Host Disease (GVHD) at Day 100
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Adverse events probably or definitely related to the vaccination and modified vaccinia Ankara vector persistence were evaluated by NCI Common Terminology Criteria for Adverse Events v5.0.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Number of Grade 3-4 Adverse Events
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 200Duration of viremia was defined as the number of days from CMV qPCR \>625 IU/mL to serum viral clearance (no detectable CMV DNA in serial blood samples).
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Duration of Viremia
|
NA days
lack of participants with events
|
NA days
lack of participants with events
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 200CMV viremia was defined CMV qPCR \>625 IU/mL from samples collected within the past 7 days.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Number of Patients With Recurrence of CMV Viremia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of transplant to date of ANC engraftment, up to Day 365.Date of ANC engraftment was defined as the first date of ANC of ≥ 0.5 x 109/L achieved for 3 consecutive lab tests on 3 different days.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Days From Transplant to ANC Engraftment
|
16 days
Interval 14.0 to 17.0
|
17 days
Interval 14.0 to 18.0
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 100Acute graft versus host disease is graded according to the 1994 Keystone Consensus Grading. The first day of acute GVHD onset was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Cumulative Incidence of Acute GVHD
|
0 percentage of participants
Insufficient number of participants with events
|
25 percentage of participants
Interval 5.0 to 100.0
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Cumulative incidence of Chronic GVHD (cGVHD) was estimated with the use of cumulative incidence curves. The first day of cGVHD onset was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Cumulative Incidence of Chronic GVHD at Day 365
|
0 percentage of participants
Insufficient number of participants with events
|
33 percentage of participants
Interval 7.0 to 100.0
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Cumulative incidence of relapse was estimated with the use of cumulative incidence curves, with death viewed as a competing risk.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Cumulative Incidence of Relapse at Day 365
|
0 percentage of participants
Insufficient number of participants with events
|
0 percentage of participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Number of participants, who died due to all causes, at Day 365 post-transplant.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Number Of Participants Died at Day 365
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Estimates was calculated using the Kaplan-Meier method, Greenwood formula was used to calculate SE, and loglog transformation method was used to construct 95% confidence intervals. Each patient's vital status was monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event was censored at his/her date of last contact.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Overall Survival at Day 365
|
100 percentage of participants
Interval 100.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: From time of transplant (Day 0) to Day 365Non-relapse mortality (NRM) was defined as death without recurrent or progressive disease after transplant. NRM was estimated with the use of cumulative incidence curves, with relapse viewed as a competing risk.
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Non-Relapse Mortality (NRM) at Day 365
|
0 percentage of participants
Insufficient number of participants with events
|
0 percentage of participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From time of transplant to date of platelet engraftment, up to Day 365Date of platelet engraftment was defined as the first date of platelet value of ≥ 20 x 109/L achieved for 3 consecutive lab tests on 3 different days (without platelet transfusion in the previous 7 days).
Outcome measures
| Measure |
Arm II (Letermovir, Placebo)
n=3 Participants
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
Arm I (Letermovir, Triplex)
n=4 Participants
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
|---|---|---|
|
Days From Transplant to Platelet Engraftment
|
28 days
Interval 18.0 to 33.0
|
23.5 days
Interval 16.0 to 28.0
|
Adverse Events
Arm I (Letermovir, Triplex)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Letermovir, Placebo)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Letermovir, Triplex)
n=4 participants at risk
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Letermovir, Placebo)
n=3 participants at risk
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
|---|---|---|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
Other adverse events
| Measure |
Arm I (Letermovir, Triplex)
n=4 participants at risk
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine: Given IM
|
Arm II (Letermovir, Placebo)
n=3 participants at risk
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Letermovir: Given as SOC
Placebo Administration: Given IM
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
66.7%
2/3 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Eye disorders
Dry eye
|
50.0%
2/4 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Eye disorders
Eye pain
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Chills
|
50.0%
2/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Edema face
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
motion sickness
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Infections and infestations
Bacteremia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
Neutrophil count decreased
|
50.0%
2/4 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Investigations
White blood cell decreased
|
75.0%
3/4 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
2/4 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
0.00%
0/3 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
4/4 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
33.3%
1/3 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
66.7%
2/3 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed at Day 100, 114, 128, 140, 180, 210-240, 270 and 365.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place