Trial Outcomes & Findings for A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients (NCT NCT04193527)
NCT ID: NCT04193527
Last Updated: 2023-10-16
Results Overview
Sensitivity was defined as positive percentage agreement and calculated as the number of true positives (TP) / (number of TP + number of false negatives \[FN\]): TP/(TP + FN), and a 2-sided 95% binomial confidence interval constructed around it. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. The sensitivity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
At Day 1
Results posted on
2023-10-16
Participant Flow
Participant milestones
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie \[mCi\]) per participant at a maximum volume of 5 milliliter \[mL\] intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
22
|
|
Overall Study
COMPLETED
|
74
|
74
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie \[mCi\]) per participant at a maximum volume of 5 milliliter \[mL\] intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Overall Study
Other
|
1
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients
Baseline characteristics by cohort
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
n=75 Participants
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
n=75 Participants
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteer (HV)
n=22 Participants
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 7.24 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 5.38 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 7.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
172 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
172 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis.
Sensitivity was defined as positive percentage agreement and calculated as the number of true positives (TP) / (number of TP + number of false negatives \[FN\]): TP/(TP + FN), and a 2-sided 95% binomial confidence interval constructed around it. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. The sensitivity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
n=75 Participants
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi per participant at a maximum volume of 5 mL) intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Reader 1-Sensitivity
|
0.851 ratio
Interval 0.75 to 0.923
|
—
|
—
|
|
Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Reader 2-Sensitivity
|
0.865 ratio
Interval 0.765 to 0.933
|
—
|
—
|
|
Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Reader 3-Sensitivity
|
0.919 ratio
Interval 0.832 to 0.97
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 1Population: Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. Only participants with a clinical diagnosis of ET were included and the HVs were excluded from the specificity analysis.
Specificity was defined as negative percentage agreement and calculated as the number of true negatives (TN) / (number of TN + number of false positives \[FP\]): TN/(TN + FP), and a 2-sided 95% binomial confidence interval constructed around it. For the specificity analysis, only participants with a clinical diagnosis of ET were included; the HVs were excluded from this analysis. The specificity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
n=75 Participants
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi per participant at a maximum volume of 5 mL) intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Reader 1-Specificity
|
0.933 ratio
Interval 0.851 to 0.978
|
—
|
—
|
|
Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Reader 2-Specificity
|
0.960 ratio
Interval 0.888 to 0.992
|
—
|
—
|
|
Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Reader 3-Specificity
|
0.813 ratio
Interval 0.707 to 0.894
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1Population: Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator.
A semi-quantitative analysis of the striatal uptake ratios in specific regions of interest (ROIs, i.e., left and right striatum, caudate, and putamen) of DaTSCAN™ SPECT images was performed with DaTQUANT™.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
n=75 Participants
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi per participant at a maximum volume of 5 mL) intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
n=75 Participants
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
n=22 Participants
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Anterior putamen right ratio
|
1.29315 ratio
Standard Deviation 0.577528
|
2.70530 ratio
Standard Deviation 0.577359
|
2.94013 ratio
Standard Deviation 0.835608
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Anterior putamen left ratio
|
1.30474 ratio
Standard Deviation 0.635803
|
2.67536 ratio
Standard Deviation 0.585852
|
2.92746 ratio
Standard Deviation 0.784174
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Caudatus asymmetry ratio
|
0.10454 ratio
Standard Deviation 0.083195
|
0.03906 ratio
Standard Deviation 0.029737
|
0.04212 ratio
Standard Deviation 0.023939
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Caudatus left ratio
|
1.70232 ratio
Standard Deviation 0.758242
|
2.87229 ratio
Standard Deviation 0.648102
|
3.05874 ratio
Standard Deviation 0.866446
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Caudatus right ratio
|
1.71398 ratio
Standard Deviation 0.660892
|
2.86571 ratio
Standard Deviation 0.616034
|
2.99258 ratio
Standard Deviation 0.885231
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Putamen to caudatus left ratio
|
0.81527 ratio
Standard Deviation 0.113790
|
0.91598 ratio
Standard Deviation 0.071819
|
0.94217 ratio
Standard Deviation 0.075958
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Putamen to caudatus right ratio
|
0.80208 ratio
Standard Deviation 0.094132
|
0.92631 ratio
Standard Deviation 0.076093
|
0.95685 ratio
Standard Deviation 0.060599
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Putamen asymmetry ratio
|
0.08884 ratio
Standard Deviation 0.070714
|
0.03472 ratio
Standard Deviation 0.026388
|
0.03066 ratio
Standard Deviation 0.022587
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Putamen left ratio
|
1.16697 ratio
Standard Deviation 0.578536
|
2.53527 ratio
Standard Deviation 0.577060
|
2.80555 ratio
Standard Deviation 0.788140
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Posterior putamen left ratio
|
0.89624 ratio
Standard Deviation 0.506444
|
2.26000 ratio
Standard Deviation 0.592376
|
2.56593 ratio
Standard Deviation 0.817882
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Posterior putamen right ratio
|
0.86673 ratio
Standard Deviation 0.514910
|
2.28143 ratio
Standard Deviation 0.583230
|
2.53907 ratio
Standard Deviation 0.861909
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Putamen right ratio
|
1.15783 ratio
Standard Deviation 0.542656
|
2.57079 ratio
Standard Deviation 0.567985
|
2.81286 ratio
Standard Deviation 0.834213
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Striatum asymmetry ratio
|
0.09290 ratio
Standard Deviation 0.069194
|
0.02879 ratio
Standard Deviation 0.023420
|
0.02774 ratio
Standard Deviation 0.019084
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Striatum left ratio
|
1.34682 ratio
Standard Deviation 0.614929
|
2.64850 ratio
Standard Deviation 0.584689
|
2.89059 ratio
Standard Deviation 0.801328
|
|
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
Striatum right ratio
|
1.32485 ratio
Standard Deviation 0.560168
|
2.65936 ratio
Standard Deviation 0.566834
|
2.86683 ratio
Standard Deviation 0.843327
|
SECONDARY outcome
Timeframe: From start of study drug administration up to Day 4Population: Safety population included all participants who received an injection of Investigational Medicinal Product (IMP).
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. A Serious Adverse Event(SAE) was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs were reported.
Outcome measures
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
n=75 Participants
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi per participant at a maximum volume of 5 mL) intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
n=75 Participants
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
n=22 Participants
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs
Participants with TEAEs
|
12 Participants
|
13 Participants
|
8 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs
Participants with Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS)
n=75 participants at risk
Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 milliliter \[mL\] intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET)
n=75 participants at risk
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
DaTSCAN™ Ioflupane: Healthy Volunteers (HV)
n=22 participants at risk
Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
4.5%
1/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Eye disorders
Dry eye
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
4.5%
1/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
4.5%
1/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
General disorders
Injection site paraesthesia
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
9.1%
2/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
4.5%
1/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
Blood glucose increased
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
9.1%
2/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
2/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
Protein urine present
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
2.7%
2/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
Neutrophil count increased
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
5/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
2.7%
2/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
1.3%
1/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
0.00%
0/75 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
4.5%
1/22 • From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place