Essential Tremor, Parkinson's Disease
Conditions
Keywords
DaTscan, Parkinson's Disease
Brief summary
The primary objective of this study is to determine if the diagnostic performance of DaTscan™ single photon emission computed tomography (SPECT) imaging is different in non-Caucasian subjects compared with Caucasian subjects with movement disorders.
Interventions
OTHERDaTscan™ - Non-Caucasian Participants
Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.
OTHERDaTscan™ - Caucasian Participants
Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.
Sponsors
H2O Clinical LLC
Quintiles, Inc.
GE Healthcare
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For Non-Caucasians: * Non-Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET. * The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain. For Caucasians: * Caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET. * The participant had existing diagnostic-quality and interpretable DaTscan SPECT images of the brain. * The participant was matched by final clinical diagnosis, sex and age (±5 years) with a non-Caucasian participant.
Exclusion criteria
* Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that could grossly distort the DaTscan images. * Participants whose race and ethnic information could not be determined from source document review.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Day 1 | The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment. |
| Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Day 1 | The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment. |
| Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Day 1 | The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment. |
| Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Day 1 | The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Day 1 | Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment. |
| Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Day 1 | Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment. |
Countries
United States
Participant flow
Recruitment details
In the present study GE-001-011 (NCT01952678), participants who previously administered DaTscan™ and had undergone single photon emission computed tomography (SPECT) imaging of the brain per local practice at each institution, were enrolled.
Pre-assignment details
A total of 102 non-Caucasian and 102 Caucasian participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| DaTscan™- Non-Caucasian Participants Non-Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET. | 102 |
| DaTscan™- Caucasian Participants Caucasian participants previously administered DaTscan™, with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the participant's final clinical diagnosis of PD or ET. | 102 |
| Total | 204 |
Baseline characteristics
| Characteristic | DaTscan™- Caucasian Participants | Total | DaTscan™- Non-Caucasian Participants |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 10.67 | 66.4 years STANDARD_DEVIATION 10.86 | 66.4 years STANDARD_DEVIATION 11.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 15 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 187 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 28 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 66 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 102 Participants | 102 Participants | 0 Participants |
| Sex: Female, Male Female | 47 Participants | 94 Participants | 47 Participants |
| Sex: Female, Male Male | 55 Participants | 110 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Time frame: Day 1
Population: ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader A | 93.0 Negative percent agreement |
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader B | 84.1 Negative percent agreement |
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader C | 86.4 Negative percent agreement |
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Majority | 88.6 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Majority | 88.4 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader A | 93.0 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader C | 88.4 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader B | 83.7 Negative percent agreement |
Comparison: Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-22, 22]Fisher Exact
Comparison: Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-20.8, 20.8]Fisher Exact
Comparison: Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-23, 18.5]Fisher Exact
Comparison: Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-20.8, 20.8]Fisher Exact
Primary
Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Time frame: Day 1
Population: PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader A | 92.5 Negative percent agreement |
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader B | 90.2 Negative percent agreement |
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader C | 90.2 Negative percent agreement |
| DaTscan™ - Non-Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Majority | 92.7 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Majority | 90.0 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader A | 92.5 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader C | 90.0 Negative percent agreement |
| DaTscan™ - Caucasian Participants | Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader B | 85.0 Negative percent agreement |
Comparison: Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-22.8, 22.8]Fisher Exact
Comparison: Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.518795% CI: [-16.7, 26.2]Fisher Exact
Comparison: Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-21.5, 21.5]Fisher Exact
Comparison: Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.712395% CI: [-19.1, 23.9]Fisher Exact
Primary
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Time frame: Day 1
Population: ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader A | 86.0 Positive percent agreement |
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader B | 78.9 Positive percent agreement |
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader C | 89.5 Positive percent agreement |
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Majority | 87.7 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Majority | 86.0 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader A | 84.2 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader C | 87.7 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader B | 86.0 Positive percent agreement |
Comparison: Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-17.3, 20.7]Fisher Exact
Comparison: Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.460895% CI: [-25.8, 12.1]Fisher Exact
Comparison: Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-17.3, 20.7]Fisher Exact
Comparison: Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-17.3, 20.7]Fisher Exact
Primary
Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.
Time frame: Day 1
Population: PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader A | 85.7 Positive percent agreement |
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader B | 78.6 Positive percent agreement |
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader C | 89.3 Positive percent agreement |
| DaTscan™ - Non-Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Majority | 87.5 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Majority | 85.7 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader A | 83.9 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader C | 87.5 Positive percent agreement |
| DaTscan™ - Caucasian Participants | Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader B | 85.7 Positive percent agreement |
Comparison: Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-17.5, 20.9]Fisher Exact
Comparison: Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.459995% CI: [-26.1, 12.2]Fisher Exact
Comparison: Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-17.5, 20.9]Fisher Exact
Comparison: Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-17.5, 20.9]Fisher Exact
Secondary
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.
Time frame: Day 1
Population: The intent-to-diagnose (ITD) population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader A | 89.0 Overall percent agreement |
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader B | 81.2 Overall percent agreement |
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader C | 88.1 Overall percent agreement |
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Majority | 88.1 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Majority | 87.0 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader A | 88.0 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader C | 88.0 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population | Reader B | 85.0 Overall percent agreement |
Comparison: Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-13.3, 15.3]Fisher Exact
Comparison: Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.573195% CI: [-17.7, 9.8]Fisher Exact
Comparison: Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-13.8, 13.8]Fisher Exact
Comparison: Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.83495% CI: [-12.8, 14.7]Fisher Exact
Secondary
Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.
Time frame: Day 1
Population: PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader A | 88.5 Overall percent agreement |
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader B | 83.5 Overall percent agreement |
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader C | 89.7 Overall percent agreement |
| DaTscan™ - Non-Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Majority | 89.7 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Majority | 87.5 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader A | 87.5 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader C | 88.5 Overall percent agreement |
| DaTscan™ - Caucasian Participants | Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population | Reader B | 85.4 Overall percent agreement |
Comparison: Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 195% CI: [-13.5, 15.6]Fisher Exact
Comparison: Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.842995% CI: [-16.1, 12]Fisher Exact
Comparison: Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.821495% CI: [-13, 15]Fisher Exact
Comparison: Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participantsp-value: 0.657795% CI: [-12, 16.1]Fisher Exact