NCT02981368 · OUTCOME
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Source last updated 2021-08-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
What was measured
Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Analysis population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
Groups in this outcome
Cohort A - Follow-up Value: Low
Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B - Follow-up Value: Low
Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Cohort A - Follow-up Value: Normal
Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B - Follow-up Value Normal
Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Cohort A - Follow-up Value: High
Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B - Follow-up Value: High
Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Cohort A - Follow-up Value: Missing
Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B - Follow-up Value: Missing
Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A - Follow-up Value: Low | 268 |
|---|
| Cohort B - Follow-up Value: Low | 117 |
|---|
| Cohort A - Follow-up Value: Normal | 268 |
|---|
| Cohort B - Follow-up Value Normal | 117 |
|---|
| Cohort A - Follow-up Value: High | 268 |
|---|
| Cohort B - Follow-up Value: High | 117 |
|---|
| Cohort A - Follow-up Value: Missing | 268 |
|---|
| Cohort B - Follow-up Value: Missing | 117 |
|---|
Reported measurements
Hematocrit
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A - Follow-up Value: Low | 55 |
|---|
| Cohort B - Follow-up Value: Low | 32 |
|---|
| Cohort A - Follow-up Value: Normal | 197 |
|---|
| Cohort B - Follow-up Value Normal | 53 |
|---|
| Cohort A - Follow-up Value: High | 2 |
|---|
| Cohort B - Follow-up Value: High | 0 |
|---|
| Cohort A - Follow-up Value: Missing | 14 |
|---|
| Cohort B - Follow-up Value: Missing | 32 |
|---|
Cohort A - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 179 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Hemoglobin
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A - Follow-up Value: Low | 34 |
|---|
| Cohort B - Follow-up Value: Low | 35 |
|---|
| Cohort A - Follow-up Value: Normal | 218 |
|---|
| Cohort B - Follow-up Value Normal | 50 |
|---|
| Cohort A - Follow-up Value: High | 2 |
|---|
| Cohort B - Follow-up Value: High | 0 |
|---|
| Cohort A - Follow-up Value: Missing | 14 |
|---|
| Cohort B - Follow-up Value: Missing | 32 |
|---|
Cohort A - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 210 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A - Follow-up Value: Low | 16 |
|---|
| Cohort B - Follow-up Value: Low | 12 |
|---|
| Cohort A - Follow-up Value: Normal | 237 |
|---|
| Cohort B - Follow-up Value Normal | 72 |
|---|
| Cohort A - Follow-up Value: High | 1 |
|---|
| Cohort B - Follow-up Value: High | 1 |
|---|
| Cohort A - Follow-up Value: Missing | 14 |
|---|
| Cohort B - Follow-up Value: Missing | 32 |
|---|
Cohort A - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 230 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Erythrocytes
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A - Follow-up Value: Low | 49 |
|---|
| Cohort B - Follow-up Value: Low | 42 |
|---|
| Cohort A - Follow-up Value: Normal | 205 |
|---|
| Cohort B - Follow-up Value Normal | 42 |
|---|
| Cohort A - Follow-up Value: High | 0 |
|---|
| Cohort B - Follow-up Value: High | 1 |
|---|
| Cohort A - Follow-up Value: Missing | 14 |
|---|
| Cohort B - Follow-up Value: Missing | 32 |
|---|
Cohort A - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 194 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A - Follow-up Value: Low | 11 |
|---|
| Cohort B - Follow-up Value: Low | 7 |
|---|
| Cohort A - Follow-up Value: Normal | 220 |
|---|
| Cohort B - Follow-up Value Normal | 75 |
|---|
| Cohort A - Follow-up Value: High | 23 |
|---|
| Cohort B - Follow-up Value: High | 3 |
|---|
| Cohort A - Follow-up Value: Missing | 14 |
|---|
| Cohort B - Follow-up Value: Missing | 32 |
|---|
Cohort A - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Low
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 208 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Normal
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 71 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: High
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort A - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cohort B - Baseline Value: Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Low | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value Normal | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: High | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort A - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort B - Follow-up Value: Missing | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 10
- title
- Cohort B - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 179
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 47
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 22
- title
- Cohort B - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Missing
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: Missing
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 197
- group Id
- OG003
- value
- 53
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 32
- units
- Participants
- title
- Hematocrit
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 13
- title
- Cohort B - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 210
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 43
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 18
- title
- Cohort B - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- title
- Cohort B - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Missing
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: Missing
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 218
- group Id
- OG003
- value
- 50
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 32
- units
- Participants
- title
- Hemoglobin
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- title
- Cohort B - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 230
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 70
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 29
- title
- Cohort B - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Missing
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: Missing
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 237
- group Id
- OG003
- value
- 72
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 32
- units
- Participants
- title
- Platelets
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 10
- title
- Cohort B - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 194
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 39
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 22
- title
- Cohort B - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Missing
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: Missing
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 205
- group Id
- OG003
- value
- 42
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 32
- units
- Participants
- title
- Erythrocytes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- title
- Cohort B - Baseline Value: Low
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 208
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 71
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 30
- title
- Cohort B - Baseline Value: Normal
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: High
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort A - Baseline Value: Missing
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Cohort B - Baseline Value: Missing
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 220
- group Id
- OG003
- value
- 75
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 32
- units
- Participants
- title
- Leukocytes
- denoms
- counts
- group Id
- OG000
- value
- 268
- group Id
- OG001
- value
- 117
- group Id
- OG002
- value
- 268
- group Id
- OG003
- value
- 117
- group Id
- OG004
- value
- 268
- group Id
- OG005
- value
- 117
- group Id
- OG006
- value
- 268
- group Id
- OG007
- value
- 117
- units
- Participants
- description
- Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
- groups
- description
- Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
- id
- OG000
- title
- Cohort A - Follow-up Value: Low
- description
- Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
- id
- OG001
- title
- Cohort B - Follow-up Value: Low
- description
- Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
- id
- OG002
- title
- Cohort A - Follow-up Value: Normal
- description
- Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
- id
- OG003
- title
- Cohort B - Follow-up Value Normal
- description
- Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
- id
- OG004
- title
- Cohort A - Follow-up Value: High
- description
- Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
- id
- OG005
- title
- Cohort B - Follow-up Value: High
- description
- Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
- id
- OG006
- title
- Cohort A - Follow-up Value: Missing
- description
- Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
- id
- OG007
- title
- Cohort B - Follow-up Value: Missing
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Set includes all participants who received any amount of 18F-DCFPyL.
- reporting Status
- POSTED
- time Frame
- From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
- title
- Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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