NCT04186845 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- groups
- description
- Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron emission tomography scan: Imaging scan with radioligand
- id
- BG000
- title
- Single Arm
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 121
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 270
- title
- >=65 years
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 7.92
- value
- 68.3
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 391
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 18
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 342
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 31
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 61
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Black or African American
- categories
- measurements
- group Id
- BG000
- value
- 295
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- White
- categories
- measurements
- group Id
- BG000
- value
- 14
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Other
- categories
- measurements
- group Id
- BG000
- value
- 21
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Not Reported
- description
- Race split into 3 substantive categories and also those for whom it was not reported
- param Type
- NUMBER
- title
- Race/Ethnicity, Customized
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 9
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Netherlands
- categories
- measurements
- group Id
- BG000
- value
- 375
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 7
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Finland
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 39
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- ≤6
- categories
- measurements
- group Id
- BG000
- value
- 232
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =7
- categories
- measurements
- group Id
- BG000
- value
- 41
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =8
- categories
- measurements
- group Id
- BG000
- value
- 63
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =9
- categories
- measurements
- group Id
- BG000
- value
- 1
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =10
- categories
- measurements
- group Id
- BG000
- value
- 15
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Gleason score (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Score 6 - The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Score 7 - Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Score 8 - Some cells look abnormal. The cancer might grow quickly or at a moderate rate Score 9 or 10 - The cells look very abnormal. The cancer is likely to grow quickly
- param Type
- NUMBER
- title
- Total Gleason Score
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 39
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =1
- categories
- measurements
- group Id
- BG000
- value
- 104
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =2
- categories
- measurements
- group Id
- BG000
- value
- 116
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =3
- categories
- measurements
- group Id
- BG000
- value
- 41
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =4
- categories
- measurements
- group Id
- BG000
- value
- 64
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =5
- categories
- measurements
- group Id
- BG000
- value
- 27
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- GGG (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Group 1: The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Group 2: Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Group 3: The cells look less like normal prostate cells. The cancer is likely to grow at a moderate rate Group 4: Some cells look abnormal. The cancer might grow quickly or at a moderate rate Group 5: The cells look very abnormal. The cancer is likely to grow quickly
- param Type
- NUMBER
- title
- Gleason Grade Group (GGG)
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T1
- categories
- measurements
- group Id
- BG000
- value
- 54
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T1c
- categories
- measurements
- group Id
- BG000
- value
- 52
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2
- categories
- measurements
- group Id
- BG000
- value
- 15
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2a
- categories
- measurements
- group Id
- BG000
- value
- 10
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2b
- categories
- measurements
- group Id
- BG000
- value
- 63
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2c
- categories
- measurements
- group Id
- BG000
- value
- 10
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T3
- categories
- measurements
- group Id
- BG000
- value
- 82
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T3a
- categories
- measurements
- group Id
- BG000
- value
- 68
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T3b
- categories
- measurements
- group Id
- BG000
- value
- 2
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T4
- categories
- measurements
- group Id
- BG000
- value
- 7
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- TX
- categories
- measurements
- group Id
- BG000
- value
- 24
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Pathological TNM stage was used if available, otherwise the clinical TNM was used. T1 means the cancer is too small to be seen on a scan, or felt during an examination of the prostate T1a means that the cancer is in less than 5% of the removed tissue T1c cancers are found by biopsy T2 means the cancer is completely inside the prostate gland T3a means the cancer has broken through the capsule (covering) of the prostate gland T3b means the cancer has spread into the tubes that carry semen (seminal vesicles) T4 means the cancer has spread into other body organs nearby
- param Type
- NUMBER
- title
- TNM (Tumor-Node-Metastasis) Stage T
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 249
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- N0
- categories
- measurements
- group Id
- BG000
- value
- 53
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- N1
- categories
- measurements
- group Id
- BG000
- value
- 61
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- NX
- categories
- measurements
- group Id
- BG000
- value
- 28
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Pathological TNM stage was used if available, otherwise the clinical TNM was used. N0 means that the nearby lymph nodes don't contain cancer cells N1 means there are cancer cells in lymph nodes near the prostate
- param Type
- NUMBER
- title
- TNM Stage N
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 243
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- M0
- categories
- measurements
- group Id
- BG000
- value
- 1
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- M1
- categories
- measurements
- group Id
- BG000
- value
- 1
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- M1b
- categories
- measurements
- group Id
- BG000
- value
- 106
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- MX
- categories
- measurements
- group Id
- BG000
- value
- 40
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Pathological TNM stage was used if available, otherwise the clinical TNM was used. M0 means the cancer hasn't spread to other parts of your body. M1 means the cancer has spread to other parts of the body outside the pelvis. It is split into M1a, M1b and M1c. M1a means there are cancer cells in lymph nodes outside the pelvis M1b means there are cancer cells in the bone M1c means there are cancer cells in other parts of the body such as the lungs
- param Type
- NUMBER
- title
- TNM Stage M
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 4.740
- value
- 28.68
- denoms
- counts
- group Id
- BG000
- value
- 334
- units
- Participants
- description
- BMI was calculated as weight in kg divided by height in m2.
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- population Description
- Not all subjects had height and weight measured (eg only 337 subjects had height at baseline) - the trial was conducted during the Covid pandemic.
- title
- Body Mass Index (BMI)
- unit Of Measure
- Kg/m2
- population Description
- All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- groups
- description
- Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan rhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning Positron emission tomography scan: Imaging scan with radioligand
- id
- BG000
- title
- Single Arm
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 121
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 270
- title
- >=65 years
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 7.92
- value
- 68.3
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 391
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 18
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 342
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 31
- title
- Unknown or Not Reported
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 61
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Black or African American
- categories
- measurements
- group Id
- BG000
- value
- 295
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- White
- categories
- measurements
- group Id
- BG000
- value
- 14
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Other
- categories
- measurements
- group Id
- BG000
- value
- 21
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Not Reported
- description
- Race split into 3 substantive categories and also those for whom it was not reported
- param Type
- NUMBER
- title
- Race/Ethnicity, Customized
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 9
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Netherlands
- categories
- measurements
- group Id
- BG000
- value
- 375
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 7
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Finland
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 39
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- ≤6
- categories
- measurements
- group Id
- BG000
- value
- 232
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =7
- categories
- measurements
- group Id
- BG000
- value
- 41
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =8
- categories
- measurements
- group Id
- BG000
- value
- 63
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =9
- categories
- measurements
- group Id
- BG000
- value
- 1
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =10
- categories
- measurements
- group Id
- BG000
- value
- 15
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Gleason score (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Score 6 - The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Score 7 - Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Score 8 - Some cells look abnormal. The cancer might grow quickly or at a moderate rate Score 9 or 10 - The cells look very abnormal. The cancer is likely to grow quickly
- param Type
- NUMBER
- title
- Total Gleason Score
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 39
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =1
- categories
- measurements
- group Id
- BG000
- value
- 104
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =2
- categories
- measurements
- group Id
- BG000
- value
- 116
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =3
- categories
- measurements
- group Id
- BG000
- value
- 41
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =4
- categories
- measurements
- group Id
- BG000
- value
- 64
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- =5
- categories
- measurements
- group Id
- BG000
- value
- 27
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- GGG (defined by the International Society of Urological Pathologists) was based on prostate biopsy. Group 1: The cells look similar to normal prostate cells. The cancer is likely to grow very slowly, if at all Group 2: Most cells still look similar to normal prostate cells. The cancer is likely to grow slowly Group 3: The cells look less like normal prostate cells. The cancer is likely to grow at a moderate rate Group 4: Some cells look abnormal. The cancer might grow quickly or at a moderate rate Group 5: The cells look very abnormal. The cancer is likely to grow quickly
- param Type
- NUMBER
- title
- Gleason Grade Group (GGG)
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T1
- categories
- measurements
- group Id
- BG000
- value
- 54
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T1c
- categories
- measurements
- group Id
- BG000
- value
- 52
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2
- categories
- measurements
- group Id
- BG000
- value
- 15
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2a
- categories
- measurements
- group Id
- BG000
- value
- 10
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2b
- categories
- measurements
- group Id
- BG000
- value
- 63
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T2c
- categories
- measurements
- group Id
- BG000
- value
- 10
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T3
- categories
- measurements
- group Id
- BG000
- value
- 82
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T3a
- categories
- measurements
- group Id
- BG000
- value
- 68
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T3b
- categories
- measurements
- group Id
- BG000
- value
- 2
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- T4
- categories
- measurements
- group Id
- BG000
- value
- 7
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- TX
- categories
- measurements
- group Id
- BG000
- value
- 24
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Pathological TNM stage was used if available, otherwise the clinical TNM was used. T1 means the cancer is too small to be seen on a scan, or felt during an examination of the prostate T1a means that the cancer is in less than 5% of the removed tissue T1c cancers are found by biopsy T2 means the cancer is completely inside the prostate gland T3a means the cancer has broken through the capsule (covering) of the prostate gland T3b means the cancer has spread into the tubes that carry semen (seminal vesicles) T4 means the cancer has spread into other body organs nearby
- param Type
- NUMBER
- title
- TNM (Tumor-Node-Metastasis) Stage T
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 249
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- N0
- categories
- measurements
- group Id
- BG000
- value
- 53
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- N1
- categories
- measurements
- group Id
- BG000
- value
- 61
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- NX
- categories
- measurements
- group Id
- BG000
- value
- 28
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Pathological TNM stage was used if available, otherwise the clinical TNM was used. N0 means that the nearby lymph nodes don't contain cancer cells N1 means there are cancer cells in lymph nodes near the prostate
- param Type
- NUMBER
- title
- TNM Stage N
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 243
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- M0
- categories
- measurements
- group Id
- BG000
- value
- 1
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- M1
- categories
- measurements
- group Id
- BG000
- value
- 1
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- M1b
- categories
- measurements
- group Id
- BG000
- value
- 106
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- MX
- categories
- measurements
- group Id
- BG000
- value
- 40
- denoms
- counts
- group Id
- BG000
- value
- 391
- units
- Participants
- title
- Missing
- description
- Pathological TNM stage was used if available, otherwise the clinical TNM was used. M0 means the cancer hasn't spread to other parts of your body. M1 means the cancer has spread to other parts of the body outside the pelvis. It is split into M1a, M1b and M1c. M1a means there are cancer cells in lymph nodes outside the pelvis M1b means there are cancer cells in the bone M1c means there are cancer cells in other parts of the body such as the lungs
- param Type
- NUMBER
- title
- TNM Stage M
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 4.740
- value
- 28.68
- denoms
- counts
- group Id
- BG000
- value
- 334
- units
- Participants
- description
- BMI was calculated as weight in kg divided by height in m2.
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- population Description
- Not all subjects had height and weight measured (eg only 337 subjects had height at baseline) - the trial was conducted during the Covid pandemic.
- title
- Body Mass Index (BMI)
- unit Of Measure
- Kg/m2
- population Description
- All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.
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Preserved source evidence · Not medical advice
Triangle