Trial Outcomes & Findings for An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS) (NCT NCT03157167)
NCT ID: NCT03157167
Last Updated: 2025-03-05
Results Overview
Cohort 1 (100 mcg/ 5mCi) was conducted first. A safety data review meeting was held after completion of Cohort 1 and again after completion of Cohort 2 at which the principal investigators and sponsor representatives reviewed the safety data to determine whether to proceed to the next cohort. All cohorts were evaluated for safety. Safety evaluations included AEs, clinical laboratory tests, vital signs, physical examinations, and ECGs. The data table includes the number of safety signals detected during the evaluation for each cohort.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
10 days after IV Tc 99m tilmanocept administration
Results posted on
2025-03-05
Participant Flow
One subject was enrolled and injected with Tc 99m tilmanocept but after experiencing an AE (anxiety) did not undergo imaging and withdrew from the trial. The safety population is defined as any subject that was injected with Tc 99m tilmanocept (15 subjects). The intent to diagnose population is defined as all subjects that completed the trial (14 subjects), unless otherwise noted in the outcome measure. One subject in cohort 1 withdrew after injection and was not imaged.
Participant milestones
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
6
|
|
Overall Study
Safety Population
|
5
|
4
|
6
|
|
Overall Study
Intent to Diagnose Population
|
4
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)
Baseline characteristics by cohort
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=5 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
n=6 Participants
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
53.5 years
n=7 Participants
|
38.5 years
n=5 Participants
|
54.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 days after IV Tc 99m tilmanocept administrationPopulation: Safety population, including all subjects injected with Tc99m tilmanocept.
Cohort 1 (100 mcg/ 5mCi) was conducted first. A safety data review meeting was held after completion of Cohort 1 and again after completion of Cohort 2 at which the principal investigators and sponsor representatives reviewed the safety data to determine whether to proceed to the next cohort. All cohorts were evaluated for safety. Safety evaluations included AEs, clinical laboratory tests, vital signs, physical examinations, and ECGs. The data table includes the number of safety signals detected during the evaluation for each cohort.
Outcome measures
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=5 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
n=6 Participants
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
To Determine the Safety of Escalating Doses of Tc 99m Tilmanocept in HIV Subjects With Biopsy-confirmed KS.
|
0 Safety Signals
|
0 Safety Signals
|
0 Safety Signals
|
SECONDARY outcome
Timeframe: 10 days after IV Tc 99m tilmanocept administrationPopulation: The intent to diagnose population, including subjects that were imaged and completed the trial.
Presents Tc 99m tilmanocept KS lesion localization in each cohort. IV injections occurred in all three cohorts. SC injections occurred in cohort 3 only.
Outcome measures
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
n=6 Participants
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Per Subject Localization Rate of Tc 99m Tilmanocept in at Least One KS Suspected or Confirmed Lesion by Planar and/or SPECT/CT Imaging
Localized KS Lesions for IV Injection
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Per Subject Localization Rate of Tc 99m Tilmanocept in at Least One KS Suspected or Confirmed Lesion by Planar and/or SPECT/CT Imaging
Localized KS Lesions for SC Injection
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 10 days after IV Tc 99m tilmanocept administrationPopulation: The intent to diagnose population, including subjects that were imaged and completed the trial, excluding cohort 1 as this cohort was completed before this outcome measure was introduced.
Localization intensity for each biopsied and clinically defined lesion was to be determined by Planar and/or SPECT/CT imaging. The results would have been average pixel intensity and percentage above background. Note: Cohort 1 was completed before this outcome measure was introduced, therefore no cohort 1 subjects were evaluated for this outcome measure.
Outcome measures
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=6 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose.
Subjects Evaluated
|
4 Participants
|
6 Participants
|
—
|
|
Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose.
Biopsy Sample Collection Criteria Met
|
0 Participants
|
1 Participants
|
—
|
|
Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose.
Participants with Valid Biopsy Imaged by SPECT/CT
|
—
|
1 Participants
|
—
|
|
Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose.
Participants with Valid Biopsy Imaged by Planar Image
|
—
|
0 Participants
|
—
|
|
Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose.
Participant with Valid Biopsy that was able to be Quantified
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 10 days after IV Tc 99m tilmanocept administrationPopulation: The intent to diagnose population, including subjects that were imaged and completed the trial.
Per lesion/region concordance of IV vs subcutaneous Tc 99m localization with anatomical areas of active KS defined by confirmed diagnosis or clinical symptomology. Note: IV routes of administration are used in all three cohorts. Cohort 3 is the only SC route of administration.
Outcome measures
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=13 Lesions
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=9 Lesions
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
n=23 Lesions
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Localization Concordance of Subcutaneous Injection and IV Injection
Localized Lesions via IV
|
3 Lesions
|
0 Lesions
|
0 Lesions
|
|
Localization Concordance of Subcutaneous Injection and IV Injection
Localized Lesions via SC
|
—
|
—
|
1 Lesions
|
SECONDARY outcome
Timeframe: 10 days after IV Tc 99m tilmanocept administrationPopulation: The intent to diagnose population, including subjects that were imaged and completed the trial, excluding cohort 1 as this cohort was completed before this outcome measure was introduced.
Quantify HHV8 in biopsied KS lesions by using qPCR. Note: Cohort 1 was completed before this outcome measure was introduced, therefore no cohort 1 subjects were evaluated for this outcome measure. If there is identification of HHv8, that would confirm the presence of KS cells in the biopsied tissue.
Outcome measures
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=6 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Exploratory: Quantify HHV8 in Biopsied KS Lesions. Mean and Standard Deviation Results.
|
1242.50 HHV8 (RFU)
Standard Deviation 583.635
|
4392.50 HHV8 (RFU)
Standard Deviation 4143.048
|
—
|
SECONDARY outcome
Timeframe: 10 days after IV Tc 99m tilmanocept administrationPopulation: The intent to diagnose population, including subjects that were imaged and completed the trial, excluding cohort 1 as this cohort was completed before this outcome measure was introduced.
Quantify HHV8 in biopsied KS lesions by using qPCR. Note: Cohort 1 was completed before this outcome measure was introduced, therefore no cohort 1 subjects were evaluated for this outcome measure. If there is identification of HHv8, that would confirm the presence of KS cells in the biopsied tissue.
Outcome measures
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=4 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=6 Participants
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Exploratory: Quantify HHV8 in Biopsied KS Lesions. Median Results.
|
1171.50 HHV8 (RFU)
Interval 606.0 to 2021.0
|
4463.50 HHV8 (RFU)
Interval 73.0 to 10507.0
|
—
|
Adverse Events
100 mcg/5 mCi Tc99m-Tilmanocept
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 mcg/10 mCi Tc99m-Tilmanocept
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200 mcg/5 mCi Tc99m-Tilmanocept
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 mcg/5 mCi Tc99m-Tilmanocept
n=5 participants at risk
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi. Note that one additional subject was injected with Tc 99m tilmanocept but withdrew after experiencing anxiety (AE). This brings the safety population for this cohort to 5.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
100 mcg/10 mCi Tc99m-Tilmanocept
n=4 participants at risk
Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
200 mcg/5 mCi Tc99m-Tilmanocept
n=6 participants at risk
Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.
Tc99m-tilmanocept: Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • 50 days
No deaths occurred during the trial. No SAEs were reported. No other significant AEs were reported.
|
0.00%
0/4 • 50 days
No deaths occurred during the trial. No SAEs were reported. No other significant AEs were reported.
|
0.00%
0/6 • 50 days
No deaths occurred during the trial. No SAEs were reported. No other significant AEs were reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • 50 days
No deaths occurred during the trial. No SAEs were reported. No other significant AEs were reported.
|
25.0%
1/4 • Number of events 1 • 50 days
No deaths occurred during the trial. No SAEs were reported. No other significant AEs were reported.
|
0.00%
0/6 • 50 days
No deaths occurred during the trial. No SAEs were reported. No other significant AEs were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place